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Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD). Having alternative injection sites is desirable to provide additional flexibility to patients, particularly for those who may prefer less visible or more convenient injection locations.
The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release Buprenorphine: Abdomen | Active Comparator | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. |
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| Extended-release Buprenorphine: Upper Arm | Experimental | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. |
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| Extended-release Buprenorphine: Buttocks | Experimental | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. |
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| Extended-release Buprenorphine: Thigh | Experimental | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine Extended-Release Injection | Drug | Administered as a subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine | Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29 | |
| Maximum Observed Plasma Concentration (Cmax) of Buprenorphine | Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-emergent Adverse Events | 28 days | |
| Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions | 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Director Clinical Development | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States | ||
| Research Centers of America |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39543001 | Derived | Laffont CM, Lapeyra O, Mangal D, Dobbins R. A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder. Clin Drug Investig. 2024 Dec;44(12):939-949. doi: 10.1007/s40261-024-01406-7. Epub 2024 Nov 14. |
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A total of 175 participants were screened to assess eligibility; of these, 132 received SUBOXONE during the Run-In Period (all eligible participants were attempted to be stabilized on 12 mg SUBOXONE [buprenorphine/naloxone] sublingual film once daily for a minimum of 7 days before the SUBLOCADE injection). 44 participants discontinued during the Run-In Period. A total of 88 participants were thus randomized (Started) to a treatment arm to receive extended-release buprenorphine on Day 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended-release Buprenorphine: Abdomen | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| FG001 | Extended-release Buprenorphine: Upper Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 18, 2022 | Oct 28, 2024 |
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| Number of Participants With Treatment-emergent Serious Adverse Events |
| 28 days |
| Injection Site Grading | Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale. | Day 1 at 10 minutes and 2 hours post dosing |
| Injection Site Pain | Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain. | Day 1 at 1, 5, 10, 15, and 30 minutes post dosing |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Miami Lakes Medical Research | Miami Lakes | Florida | 33016 | United States |
| Rivus Wellness and Research Institute | Oklahoma City | Oklahoma | 73112 | United States |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| FG002 | Extended-release Buprenorphine: Buttocks | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| FG003 | Extended-release Buprenorphine: Thigh | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended-release Buprenorphine: Abdomen | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| BG001 | Extended-release Buprenorphine: Upper Arm | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| BG002 | Extended-release Buprenorphine: Buttocks | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| BG003 | Extended-release Buprenorphine: Thigh | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine | Pharmacokinetic Evaluable Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Buprenorphine | Pharmacokinetic Evaluable Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29 |
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| Secondary | Participants With Treatment-emergent Adverse Events | Safety Analysis Set | Posted | Number | Percentage of participants | 28 days |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions | Safety Analysis Set | Posted | Number | Percentage of participants | 28 days |
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| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events | Safety Analysis Set | Posted | Number | Percentage of participants | 28 days |
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| Secondary | Injection Site Grading | Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale. | Safety Analysis Set | Posted | Number | Percentage of participants | Day 1 at 10 minutes and 2 hours post dosing |
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| Secondary | Injection Site Pain | Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain. | Safety Analysis Set | Posted | Mean | Standard Deviation | score on a scale | Day 1 at 1, 5, 10, 15, and 30 minutes post dosing |
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Up to 86 days
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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 | Pre-injection (Run-In Period) | Participants who received SUBOXONE during the Run-In Period (all eligible participants were attempted to be stabilized on 12 mg SUBOXONE [buprenorphine/naloxone] sublingual film once daily for a minimum of 7 days before injection with extended-release buprenorphine). 44 participants discontinued during the Run-In Period. | 0 | 132 | 0 | 132 | 26 | 132 |
| EG001 | Extended-release Buprenorphine: Abdomen (Post-injection) | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. | 0 | 22 | 0 | 22 | 5 | 22 |
| EG002 | Extended-release Buprenorphine: Upper Arm (Post-injection) | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. | 0 | 21 | 0 | 21 | 3 | 21 |
| EG003 | Extended-release Buprenorphine: Buttocks (Post-injection) | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. | 0 | 22 | 0 | 22 | 4 | 22 |
| EG004 | Extended-release Buprenorphine: Thigh (Post-injection) | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. | 0 | 23 | 0 | 23 | 2 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Director Clinical Development | Indivior Inc. | (804) 594-4488 | trialdisclosure@indivior.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Primary | Oct 23, 2023 | Oct 28, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Addendum | Mar 19, 2024 | Oct 28, 2024 | SAP_002.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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| ID | Term |
|---|---|
| C000627685 | Sublocade |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Extended-release Buprenorphine: Thigh |
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
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Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
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Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
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| OG003 | Extended-release Buprenorphine: Thigh | Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
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| Extended-release Buprenorphine: Thigh |
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection. |
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