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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA013035-19 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-inferior to a Standard Method (13-day long) on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection). Secondary objectives include comparing Rapid versus Standard method on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient induction process and the first two months of post-induction XR-NTX maintenance. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.
The overarching objective of the SWIFT trial (CTN-0097) is to foster widespread adoption of a regimen for rapid initiation of treatment with extended-release injection naltrexone (XR-NTX) at inpatient or residential Community Treatment Programs (CTPs). If widely adopted, such a regimen would have a substantial public health impact by expanding medication treatment options offered to patients with OUD to include XR-NTX.
In multi-site, randomized (subject level) trials, XR-NTX, once initiated, has been found to have similar effectiveness to sublingual buprenorphine on clinical outcomes of retention in treatment and abstinence from opioids. However, initiation of naltrexone often involves a significant (up to 2 weeks) delay, which is a clinical hurdle that impedes the widespread adoption of XR-NTX as a treatment option. Initiation of naltrexone in patients actively using opioids requires that a patient be detoxified first, and the official prescribing information for XR-NTX recommends an additional 7- to 10-day waiting period after last dose of opioid before administering XR-NTX. This standard initiation regimen, involving a brief period of agonist, usually buprenorphine, taper followed by a 7- to 10-day waiting period, takes approximately two weeks. During this time, patients are vulnerable to drop out and relapse; further, this waiting period is problematic in the face of funding restrictions on the duration of inpatient stays. In a single-site randomized trial, a Rapid naltrexone induction method utilizing minimal buprenorphine, non-opioid medications to treat withdrawal symptoms, and upward titration of oral naltrexone starting with small doses, XR-NTX initiation was accomplished in 5 to 7 days and was found superior to the standard 14-day approach on the proportion of patients initiating XR-NTX.
The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid method of initiating treatment with XR-NTX is non-inferior to a standard method on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection) when implemented at community-based inpatient or residential programs. Secondary objectives include comparing rapid versus standard method of XR-NTX initiation on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient initiation process and the first two months post XR-NTX induction. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Induction Method | Active Comparator | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period |
|
| Rapid Induction Method | Experimental | The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Induction Procedure (SP) | Other | SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Who Receive the First XR-NTX Injection (Dichotomous: Did or Did Not Receive First Dose of XR-NTX) | The primary goal of the study is to show RP is non-inferior to SP XR-NTX induction method. | Induction Phase: 1-30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean for Time From Admission to First XR-NTX Injection by Treatment Group. | Time to receipt of first injection of XR-NTX from day of admission for participants that receive first injection of XR-NTX. | Induction Phase: 1-30 days |
| Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Induction Phase |
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Inclusion Criteria:
Exclusion Criteria:
1. Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX, hazardous (relative contra-indications) or requires a different level of care. Examples include:
Disabling or terminal medical illness (e.g., uncompensated heart failure, severe acute hepatitis, cirrhosis or end-stage liver disease) as assessed by medical history and/or review of systems.
Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview.
Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included).
Suicidal or homicidal ideation that requires immediate attention. Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent.
3. Maintenance treatment with methadone. 4. Maintenance treatment with buprenorphine unless the patient is determined to have a poor treatment response (in the form of buprenorphine non-adherence with or without the use of illicit opioids), warranting change to XR-NTX treatment.
5. Presence of pain of sufficient severity as to require ongoing pain management with opioids.
6. Circumstances (legal, personal, occupational) that would threaten the feasibility of XR- NTX treatment or make another treatment (e.g. buprenorphine or methadone) a better choice.
7. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
8. If female, currently pregnant or breastfeeding, or planning on conception. 9. Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks, emaciation).
10. Admitted to the inpatient detoxification or residential rehabilitation unit more than 3 days prior to consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aspire Health Partners | Orlando | Florida | 32810 | United States | ||
| Avery Road Treatment Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28068780 | Result | Sullivan M, Bisaga A, Pavlicova M, Choi CJ, Mishlen K, Carpenter KM, Levin FR, Dakwar E, Mariani JJ, Nunes EV. Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine. Am J Psychiatry. 2017 May 1;174(5):459-467. doi: 10.1176/appi.ajp.2016.16050548. Epub 2017 Jan 10. | |
| 38717773 | Derived | Shulman M, Greiner MG, Tafessu HM, Opara O, Ohrtman K, Potter K, Hefner K, Jelstrom E, Rosenthal RN, Wenzel K, Fishman M, Rotrosen J, Ghitza UE, Nunes EV, Bisaga A. Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249744. doi: 10.1001/jamanetworkopen.2024.9744. |
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This study will comply with the National Institutes of Health (NIH) Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and (for HEAL-funded studies) the Helping to End Addiction Long-term (HEAL) Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).
Primary data for this study will be available to the public in the National Institute on Drug Abuse (NIDA) data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/.
The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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451 participants were found eligible at pre-screening, 32 of which did not meet eligibility criteria at screening. Of the 419 participants determined eligible at screening, 4 withdrew interest in participation or left prior to completion of screening and initiation of enrollment. The total remaining 415 were enrolled in one of the study treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Site 1: Rapid Procedure for Duration of Study (70 Weeks) | The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| FG001 | Site 2: 14 Weeks of Standard Procedure, Followed by 56 Weeks of Rapid Procedure | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. -- The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| FG002 | Site 3: 28 Weeks of Standard Procedure, Followed by 42 Weeks of Rapid Procedure | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| FG003 | Site 4: 42 Weeks of Standard Procedure, Followed by 28 Weeks of Rapid Procedure | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| FG004 | Site 5: "Standard Procedure for 56 Weeks, Followed by 14 Weeks of Rapid Procedure | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| FG005 | Site 6: Standard Procedure for Duration of the Study (70 Weeks) | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1 (Weeks 0-14) |
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| Step 2 (Weeks 14-28) |
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| Step 3 (Weeks 28-42) |
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| Step 4 (Weeks 42-56) |
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| Step 5 (Weeks 56-70) |
|
Baseline population includes participants who were enrolled in the study in either the Standard or Rapid treatment arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Induction Method | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants younger than 18 were ineligible to participate in the study. |
| 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 | The Percentage of Patients Who Receive the First XR-NTX Injection (Dichotomous: Did or Did Not Receive First Dose of XR-NTX) | The primary goal of the study is to show RP is non-inferior to SP XR-NTX induction method. | Posted | Count of Participants | Participants | Induction Phase: 1-30 days |
|
70 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Induction Method | The Standard Method (13-day long) includes 5-days of buprenorphine taper followed by 7-day washout period Standard Induction Procedure (SP): SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall Event | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenzie Potter | New York Psychiatric Institute | 2535920386 | kenzie.potter@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2021 | Sep 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2023 | Sep 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The proposed study is an open-label, multi-center, stepped-wedge cluster randomized trial. As part of the stepped-wedge design proposed for this trial, one site, randomly chosen, will start implementing the Rapid procedure (RP) and will remain in this arm for the rest of the study. The next 4 sites randomly chosen will first implement the Standard procedure (SP), to establish the within-site comparison condition, and then at selected staggered time-points (steps) will switch to implementing only the RP. The 6th site (after 5 sites have been randomized to RP) will remain in the SP procedure arm throughout the whole duration of the study. Implementation of RP at study sites will be staggered by 14 weeks and the order in which sites will cross-over from SP to RP will be randomly chosen.
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| Rapid Induction Procedure (RP) | Other | RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
|
Craving for opioids measured by Visual Analog Scales (VAS). Scale 0-100, 0 no craving and 100 Most intense craving possible |
| Induction Phase: 1-30 days |
| Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Post-induction Weeks 1 Through 8 | Craving for opioids measured by Visual Analog Scales (VAS). Scale 0-100, 0 no craving and 100 Most intense craving possible | Post Induction Phase: 1-8 weeks |
| Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Induction Phase | Opioid withdrawal symptoms as measured by the Subjective Opioid Withdrawal Scale (SOWS). Scale 0-64, with the higher score representing greater withdrawal severity. | Induction Phase: 1-30 days |
| Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Post-induction Weeks 1 Through 4 | Opioid withdrawal symptoms as measured by the Subjective Opioid Withdrawal Scale (SOWS). Scale 0-64, with the higher score representing greater withdrawal severity. | Post Induction Phase: 1 - 4 weeks |
| Mean of Individual Participant's Opioid Withdrawal Measured by Clinical Opioid Withdrawal Scale (COWS) During Induction Phase | Opioid withdrawal symptoms as measured by the Clinical Opiate Withdrawal Scale (COWS). Scale 0-59, with the higher score representing greater withdrawal severity. | Induction Phase: 1-30 days |
| Mean of Individual Participant's Opioid Craving Measured by Clinical Opioid Withdrawal Scale (COWS) During Post-induction Weeks 1 Through 4 | Opioid withdrawal symptoms as measured by the Clinical Opiate Withdrawal Scale (COWS). Scale 0-59, with the higher score representing greater withdrawal severity. | Post Induction Phase: 1 - 4 weeks |
| Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Induction Phase | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9). Scale 0-27, with the higher score representing greater severity. | Induction Phase: 1-30 days |
| Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Post-induction Weeks 1 Through 8 | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9). Scale 0-27, with the higher score representing greater severity. | Post Induction Phase: 1 - 8 weeks |
| Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Induction Phase | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Scale 0-21, with the higher score representing greater severity. | Induction Phase: 1-30 days |
| Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Post-induction Weeks 1 Through 8 | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Scale 0-21, with the higher score representing greater severity. | Post Induction Phase: 1 - 8 weeks |
| Frequency of Targeted Safety Events Related to Study Medication and Any Serious Adverse Events During Induction Period and During Eight Weeks of Post-induction Treatment | Safety, as measured by targeted safety events and serious adverse events. | Induction Phase- 1 - 30 days, Post Induction Phase- 1-8 weeks |
| Number of Medical Visits and Therapy Completed During Follow up Treatment. | Engagement with medical visits and therapy (based on medical management log, XR- NTX dose log, Psychosocial log). | Post Induction Phase: 1 - 8 weeks |
| Percent of Patients Reporting Continued Treatment With Medication for Opioid Use Disorder (MOUD) at Week 8 | Use of medication for opioid use disorder (MOUD) as measured by patient self-report on Timeline Followback (TLFB). | Post Induction Phase: Week 8 |
| Percent of Participants Positive for Opioids Using Weekly TLFB During Eight Weeks of Post-induction | Opioid abstinence, as measured by the Timeline Followback (TLFB) (self-report days using opioids) | Post Induction Phase: 1 - 8 weeks |
| Percent of Participants Positive for Opioids Using Urine Drug Screens at Week 4 and 8 | Opioid abstinence, as measured by the proportion of opioid-positive urine tests. | Post Induction Phase: Week 4 and Week 8 |
| Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Weekly TLFB During Eight Weeks of Post- Induction | Use of alcohol and other drugs of abuse (e.g., cocaine, other stimulants, cannabis, benzodiazepines), by self-report | Post Induction Phase: 1 - 8 weeks |
| Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Urine Drug Screens at Week 4 and 8 | Use of alcohol and other drugs of abuse (e.g., cocaine, other stimulants, cannabis, benzodiazepines), by urine drug screens. | Post Induction Phase: Week 4 and Week 8 |
| Proportion of Participants That Receive Second and Third Injection of XR-NTX (at 1 Month and 2 Months, From First Injection) | Retention in the trial to receive the second and the third XR-NTX injections. | Post Induction Phase: Week 4 and Week 8 |
| Rockville |
| Maryland |
| 20853 |
| United States |
| Gibson Recovery Center, Inc. | Cape Girardeau | Missouri | 63703 | United States |
| Stony Brook Eastern Long Island Hospital | Greenport | New York | 11944 | United States |
| Adapt | Roseburg | Oregon | 97470 | United States |
| Nexus Recovery Center, Inc. | Dallas | Texas | 75228 | United States |
| 36931426 | Derived | Greiner MG, Shulman M, Opara O, Potter K, Voronca DC, Tafessu HM, Hefner K, Hamilton A, Scheele C, Ho R, Dresser L, Jelstrom E, Fishman M, Ghitza UE, Rotrosen J, Nunes EV, Bisaga A. Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): A stepped wedge hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2023 May;128:107148. doi: 10.1016/j.cct.2023.107148. Epub 2023 Mar 15. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Rapid Induction Method | The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Both race and ethnicity were collected independently in this study via participant self-report in pre-determined categories. Ethnicity will be reported here. Ethnicity categories include: Hispanic or Latino, Not Hispanic or Latino, Don't know | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Both race and ethnicity were collected independently in this study via participant self-report in pre-determined categories. Race will be reported here. Race categories include: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White, Other, Multiracial, Don't know, Refused to answer | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education Completed | Categories of completed education milestones collected via participant self-report. | Count of Participants | Participants |
|
| Marital Status | Marital status collected via participant self-report | Count of Participants | Participants |
|
| Sexual-Orientation | Sexual orientation collected via participant self-report | Count of Participants | Participants |
|
| Employment | Collected via participant self-report | Count of Participants | Participants |
|
| Location participant spent the night before coming to the unit | Collected via participant self-report | Count of Participants | Participants |
|
| First COWS Score on Day 1 of admission | COWS (Clinical Opioid Withdrawal Scale) measures withdrawal symptom severity with a 0-48 point scale, with 0 points indicating no symptoms are observed, and 48 points indicating maximum severity. There are 11 items: resting pulse, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, aches, gooseflesh skin, and runny nose/tearing. Each measure has a different maximum point value depending on observed symptoms. Of the participants at baseline, 146 participants in Standard Procedure and 201 participants in Rapid Procedure had COWS assessed in this first admission day. | Not all participants who enrolled and participated in baseline data collection had COWS collected on first day of admission (baseline assessments were conducted most frequently after the first day of admission) | Mean | Standard Deviation | units on a scale |
|
| History of lifetime opioid overdose | Collected via participant self-report | Count of Participants | Participants |
|
| Number of lifetime overdoses | collected by participant self-report | 89 participants in Standard Procedure indicated history of overdose in their lifetime, and 88 of them provided data on the total number of overdoses via self-report (1 missing). 111 participants in Rapid Procedure indicated history of overdose in their lifetime, and all of them provided data on the total number of overdoses via self-reporting (none missing). | Mean | Standard Deviation | overdoses |
|
| Baseline substance use (Urine Drug Screen) | Urine drug screen results recorded after testing for adulteration and confirming sample is fit for testing. Buprenorphine taper is part of study treatment initiation, and use of benzodiazepines for treatment of withdrawal symptoms was encouraged. Number of positive tests will not match number of participants assessed because UDS categories are not mutually exclusive and participants may have a positive result for one, multiple or no substances. | Number | Number of positive test results |
|
| TLFB substance use (at least once in the past 7 days) | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| TLFB substance use (at least once in the past 30 days) | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| Type of baseline heroin/fentanyl last use from TLFB | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| Type of baseline prescription opioid last use | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| Type of baseline methadone last use | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| Type of baseline buprenorphine last use | Collected via participant self-report within the defined categories. Participants assessed will not match with reports of drug use as participants may report use of one, multiple, or none of the listed drugs. | Number | # participants with reported use |
|
| Substance use disorder | Categories from DSM-5 study assessment, completed by a physician while assessing participant. | Number | participants |
|
| OG001 |
| Rapid Induction Method |
The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given |
|
|
| Secondary | Mean for Time From Admission to First XR-NTX Injection by Treatment Group. | Time to receipt of first injection of XR-NTX from day of admission for participants that receive first injection of XR-NTX. | Only participants who received first injection of XR-NTX were analyzed for days to first injection. | Posted | Mean | Standard Deviation | Days | Induction Phase: 1-30 days |
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|
|
| Secondary | Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Induction Phase | Craving for opioids measured by Visual Analog Scales (VAS). Scale 0-100, 0 no craving and 100 Most intense craving possible | Not Posted | Induction Phase: 1-30 days | Participants |
| Secondary | Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Post-induction Weeks 1 Through 8 | Craving for opioids measured by Visual Analog Scales (VAS). Scale 0-100, 0 no craving and 100 Most intense craving possible | Not Posted | Post Induction Phase: 1-8 weeks | Participants |
| Secondary | Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Induction Phase | Opioid withdrawal symptoms as measured by the Subjective Opioid Withdrawal Scale (SOWS). Scale 0-64, with the higher score representing greater withdrawal severity. | Not Posted | Induction Phase: 1-30 days | Participants |
| Secondary | Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Post-induction Weeks 1 Through 4 | Opioid withdrawal symptoms as measured by the Subjective Opioid Withdrawal Scale (SOWS). Scale 0-64, with the higher score representing greater withdrawal severity. | Not Posted | Post Induction Phase: 1 - 4 weeks | Participants |
| Secondary | Mean of Individual Participant's Opioid Withdrawal Measured by Clinical Opioid Withdrawal Scale (COWS) During Induction Phase | Opioid withdrawal symptoms as measured by the Clinical Opiate Withdrawal Scale (COWS). Scale 0-59, with the higher score representing greater withdrawal severity. | Not Posted | Induction Phase: 1-30 days | Participants |
| Secondary | Mean of Individual Participant's Opioid Craving Measured by Clinical Opioid Withdrawal Scale (COWS) During Post-induction Weeks 1 Through 4 | Opioid withdrawal symptoms as measured by the Clinical Opiate Withdrawal Scale (COWS). Scale 0-59, with the higher score representing greater withdrawal severity. | Not Posted | Post Induction Phase: 1 - 4 weeks | Participants |
| Secondary | Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Induction Phase | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9). Scale 0-27, with the higher score representing greater severity. | Not Posted | Induction Phase: 1-30 days | Participants |
| Secondary | Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Post-induction Weeks 1 Through 8 | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9). Scale 0-27, with the higher score representing greater severity. | Not Posted | Post Induction Phase: 1 - 8 weeks | Participants |
| Secondary | Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Induction Phase | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Scale 0-21, with the higher score representing greater severity. | Not Posted | Induction Phase: 1-30 days | Participants |
| Secondary | Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Post-induction Weeks 1 Through 8 | Other depressive, anxiety, and subacute withdrawal symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Scale 0-21, with the higher score representing greater severity. | Not Posted | Post Induction Phase: 1 - 8 weeks | Participants |
| Secondary | Frequency of Targeted Safety Events Related to Study Medication and Any Serious Adverse Events During Induction Period and During Eight Weeks of Post-induction Treatment | Safety, as measured by targeted safety events and serious adverse events. | Not Posted | Induction Phase- 1 - 30 days, Post Induction Phase- 1-8 weeks | Participants |
| Secondary | Number of Medical Visits and Therapy Completed During Follow up Treatment. | Engagement with medical visits and therapy (based on medical management log, XR- NTX dose log, Psychosocial log). | Not Posted | Post Induction Phase: 1 - 8 weeks | Participants |
| Secondary | Percent of Patients Reporting Continued Treatment With Medication for Opioid Use Disorder (MOUD) at Week 8 | Use of medication for opioid use disorder (MOUD) as measured by patient self-report on Timeline Followback (TLFB). | Not Posted | Post Induction Phase: Week 8 | Participants |
| Secondary | Percent of Participants Positive for Opioids Using Weekly TLFB During Eight Weeks of Post-induction | Opioid abstinence, as measured by the Timeline Followback (TLFB) (self-report days using opioids) | Not Posted | Post Induction Phase: 1 - 8 weeks | Participants |
| Secondary | Percent of Participants Positive for Opioids Using Urine Drug Screens at Week 4 and 8 | Opioid abstinence, as measured by the proportion of opioid-positive urine tests. | Not Posted | Post Induction Phase: Week 4 and Week 8 | Participants |
| Secondary | Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Weekly TLFB During Eight Weeks of Post- Induction | Use of alcohol and other drugs of abuse (e.g., cocaine, other stimulants, cannabis, benzodiazepines), by self-report | Not Posted | Post Induction Phase: 1 - 8 weeks | Participants |
| Secondary | Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Urine Drug Screens at Week 4 and 8 | Use of alcohol and other drugs of abuse (e.g., cocaine, other stimulants, cannabis, benzodiazepines), by urine drug screens. | Not Posted | Post Induction Phase: Week 4 and Week 8 | Participants |
| Secondary | Proportion of Participants That Receive Second and Third Injection of XR-NTX (at 1 Month and 2 Months, From First Injection) | Retention in the trial to receive the second and the third XR-NTX injections. | Not Posted | Post Induction Phase: Week 4 and Week 8 | Participants |
| 1 |
| 190 |
| 7 |
| 190 |
| 7 |
| 190 |
| EG001 | Rapid Induction Method | The Rapid Method includes one day of buprenorphine followed by a day of washout and 3-4 days of oral naltrexone titration with adjunctive medications Rapid Induction Procedure (RP): RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given | 0 | 225 | 12 | 225 | 27 | 225 |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Abscess (neck) | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Drug withdrawal convulsions | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Death | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute change in mental status | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute mental complication likely exacerbated by the stress of withdrawal | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute psychiatric symptoms | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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Not provided
Not provided
| Unknown or Not Reported |
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| Divorced |
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| Separated |
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| Never married |
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| Living with partner |
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| Don't know |
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| Refused |
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| Gay or lesbian |
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| Bisexual |
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| Queer |
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| Not sure |
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| Something else |
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| Looking for work, unemployed |
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| Retired |
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| Disabled permanently or temporarily |
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| Keeping house |
|
| Student |
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| Other |
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| Own apartment, room or house - not subsidized |
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| Someone else's apartment, room or house |
|
| Hotel, SRO, or boarding home |
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| Halfway house, residential treatment program (focus: establishing sobriety) |
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| Transitional housing (focus: movement into permanent housing) |
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| Institution (hospital, nursing home, etc.) |
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| Homeless shelter |
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| Outdoors/street, abandoned/public building, vehicle, or other place not meant for human habitation |
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| Detox |
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| Other - homeless |
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| Other - stable housing |
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| Other |
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