Medication Treatment for Opioid Use Disorder in Expectant... | NCT03918850

NCT03918850

ID	Type	Description	Link
UG1DA013732	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute on Drug Abuse (NIDA)	NIH
The Emmes Company, LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BUP-XR	Experimental	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).	Drug: Buprenorphine Injection
BUP-SL	Active Comparator	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).	Drug: Buprenorphine Sublingual Product

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine Injection	Drug	Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).	BUP-XR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy	Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.	From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Illicit Opioid-negative Urine Samples Postpartum	Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.	Delivery through 12 months postpartum
Percentage of Days With Study Medication Adherence During Pregnancy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Potential participants must:

be 18-41 years of age
be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA < 12 weeks and is not planning to terminate the pregnancy
have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD
be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits
be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS
be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
be able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

Potential participants must not:

have a physiological dependence on alcohol or sedatives requiring medical detoxification
have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
- Suicidal or homicidal ideation requiring immediate attention
- Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
- aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
- serum creatinine greater than 1.5X upper limit of normal
- total bilirubin greater than 1.5X upper limit of normal
be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
be currently receiving methadone or naltrexone for the treatment of OUD;
be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;
be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.

Contacts/Locations Module

Name	Affiliation	Role
T. John Winhusen, PhD	University of Cincinnati	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Gateway Community Services		Jacksonville	Florida	32204	United States
Massachusetts General Hospital HOPE Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41837971	Derived	Winhusen TJ, Lofwall MR, Kropp F, Lewis D, Smid MC, Young JL, Hodgkins C, Krans EE, Hansen Z, Wachman EM, Schiff DM, Guille C, Rudolf V, Chowdhury T, Leeman L, Lewis M, Matthews AG, Cochran G, King J, Wilder C, Rosa C. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):533-543. doi: 10.1001/jamainternmed.2026.0057.
41429292	Derived

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 21, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
BG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00031.1± 4.6 BG00131.4± 4.7 BG00231.2± 4.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00069 BG00171 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0013 BG002

Opioid Craving Scale

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG0002.7± 2.5 BG0013.7± 3.0 BG002

Short Opioid Withdrawal Scale

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.0± 7.0 BG0015.8± 6.6 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Illicit Opioid-negative Urine Samples During Pregnancy

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Posted

Mean

Standard Error

% Illicit opioid-negative urine samples

From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks

urine samples

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Units	Counts
Participants	OG00069 OG00171
urine samples	OG0001136 OG001

Title

Denominators

Categories

Title	Measurements
	OG00082.5± 4.2 OG00172.6± 4.2

Secondary

Percentage of Illicit Opioid-negative Urine Samples Postpartum

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.

Posted

Mean

Standard Error

% Illicit opioid-negative urine samples

Delivery through 12 months postpartum

urine samples

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Percentage of Days With Study Medication Adherence During Pregnancy

Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Posted

Mean

Standard Error

percentage of expected days adherent

From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Percentage of Days With Study Medication Adherence - Postpartum

Adherence to treatment from delivery through 12 months postpartum, checked weekly.

Posted

Mean

Standard Error

percentage of expected days adherent

Delivery through 12 months postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Posted

Mean

Standard Error

Percentage of negative urine samples

From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks

urine samples

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.

Posted

Mean

Standard Error

Percentage of negative urine samples

Delivery through 12 months postpartum

urine samples

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Opioid Craving Scale - Pregnancy

The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.

Posted

Mean

Standard Error

score on a scale

Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL

Secondary

Opioid Craving Scale - Postpartum

The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported

Posted

Mean

Standard Error

score on a scale

Assessed at months 1, 3, 6, 9, and 12 post-delivery

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Adequacy of Prenatal Care Utilization Index

The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.

Posted

Number

percentage of participants

At delivery

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy

Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.

Posted

Mean

Standard Error

score on a scale

Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum

Posted

Mean

Standard Error

score on a scale

Assessed at months 1, 3, 6, 9, and 12 post-delivery

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms

Use of opioid medication for NOWS symptoms will be abstracted from the medical record.

Posted

Mean

Standard Error

Total amount of morphine for NOWS-mg

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Total Days of Neonatal Opioid Treatment During the Hospital Stay

Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.

Posted

Mean

Standard Error

Days of opioid treatment

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Infant Hospital Length of Stay

Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)

Posted

Mean

Standard Error

Hospital length of stay, days

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score

NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.

Posted

Mean

Standard Error

score on a scale

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Custody at Discharge

For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number & percentage.

Posted

Number

% of participants with maternal custody

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Child Protective Services Open Case

Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.

Posted

Number

% Case with child protective services

Neonate discharge from hospital, typically within 1 month postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Secondary

Ages and Stages Questionnaire, Third Edition (ASQ-3)

To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.

Posted

Number

% infants w/ dev. issues

12 months postpartum

ID	Title	Description
OG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
OG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BUP-XR	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).	0	69	9	69	49	69
EG001	BUP-SL	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.	0	71	27	71	59	71
EG002	BUP-XR - Neonates	Infants born to mothers in the BUP-XR arm of the study.	0	67	9	67	0	0
EG003	BUP-SL - Neonates	Infants born to mothers of the BUP-SL arm of the study.	1	70	11	70	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pre-Eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0003 affected69 at risk EG0013 affected71 at risk EG0020 affected67 at risk EG0030 affected70 at risk
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0014 affected71 at risk EG0020 affected67 at risk EG003
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Placenta accreta	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Postpartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Uterine contractions during pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Drug dependence	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Drug use disorder	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0012 affected71 at risk EG0020 affected67 at risk EG003
Major depression	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Depression	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Substance-induced mood disorder	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0013 affected71 at risk EG0020 affected67 at risk EG003
Violence-related symptom	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0002 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
COVID-19	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0012 affected71 at risk EG0020 affected67 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Sepsis	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Urosepsis	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Hospitalisation	Surgical and medical procedures	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0012 affected71 at risk EG0020 affected67 at risk EG003
Drug titration	Surgical and medical procedures	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Umbilical hernia repair	Surgical and medical procedures	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Blood pressure increased	Investigations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Seizure	Nervous system disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Retroplacental haematoma	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
Hypertension	Vascular disorders	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Chest Pain	General disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0011 affected71 at risk EG0020 affected67 at risk EG003
COVID-19 Pneumonia	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0001 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (27.1)	Systematic Assessment		EG0003 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Drug withdrawal syndrome, neonatal	General disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Death, neonatal	General disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Congenital absence of bile ducts	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Spina bifida	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Pyelocaliectasis	Renal and urinary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Hypospadias	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Weight decrease, neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected67 at risk EG003
Hypothermia	General disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Pyloric Stenosis	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected67 at risk EG003
Laryngomalacia	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected67 at risk EG003
VACTERL syndrome	Congenital, familial and genetic disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected67 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected70 at risk EG0021 affected67 at risk EG003
COVID-19	Infections and infestations	MedDRA (27.1)	Systematic Assessment	Affecting infant	EG0000 affected69 at risk EG0010 affected71 at risk EG0020 affected67 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0021 affected67 at risk EG003
Hyperbilirubinaemia, neonatal	Hepatobiliary disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected67 at risk EG003
Weight gain poor	Metabolism and nutrition disorders	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0022 affected67 at risk EG003
Echocardiogram abnormal	Investigations	MedDRA (27.1)	Systematic Assessment		EG0000 affected69 at risk EG0010 affected71 at risk EG0021 affected67 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.1)	Systematic Assessment	EG0001 affected69 at risk EG0014 affected71 at risk EG0020 at risk EG0030 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0002 affected69 at risk EG0016 affected71 at risk EG0020 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0006 affected69 at risk EG0017 affected71 at risk EG0020 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0002 affected69 at risk EG0014 affected71 at risk EG0020 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG00010 affected69 at risk EG0015 affected71 at risk EG0020 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG00012 affected69 at risk EG0017 affected71 at risk EG0020 at risk EG003
Peripheral swelling	General disorders	MedDRA (27.1)	Systematic Assessment	EG0005 affected69 at risk EG0012 affected71 at risk EG0020 at risk EG003
COVID-19	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0009 affected69 at risk EG00115 affected71 at risk EG0020 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0006 affected69 at risk EG0013 affected71 at risk EG0020 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0001 affected69 at risk EG0016 affected71 at risk EG0020 at risk EG003
Tooth infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0001 affected69 at risk EG0015 affected71 at risk EG0020 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG00010 affected69 at risk EG00111 affected71 at risk EG0020 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0004 affected69 at risk EG0019 affected71 at risk EG0020 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected69 at risk EG0016 affected71 at risk EG0020 at risk EG003
Headache	Nervous system disorders	MedDRA (27.1)	Systematic Assessment	EG0006 affected69 at risk EG0018 affected71 at risk EG0020 at risk EG003
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions	MedDRA (27.1)	Systematic Assessment	EG0000 affected69 at risk EG0014 affected71 at risk EG0020 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected69 at risk EG0014 affected71 at risk EG0020 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (27.1)	Systematic Assessment	EG0002 affected69 at risk EG0014 affected71 at risk EG0020 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0001 affected69 at risk EG0015 affected71 at risk EG0020 at risk EG003
Hypertension	Vascular disorders	MedDRA (27.1)	Systematic Assessment	EG0004 affected69 at risk EG0013 affected71 at risk EG0020 at risk EG003
Bacterial Vaginosis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected69 at risk EG0015 affected71 at risk EG0020 at risk EG003

First MCP Posted Date

ID	Term
D009293	Opioid-Related Disorders
D019966	Substance-Related Disorders
D009357	Neonatal Abstinence Syndrome

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D002047	Buprenorphine
D000069479	Buprenorphine, Naloxone Drug Combination

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds
D009270	Naloxone
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

Units	Counts
Participants	OG00067 OG00169

Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.

The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).

Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.

Units	Counts
Participants	OG00030 OG00136