Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
NCT ID: NCT05704543
Last Updated: 2025-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2023-03-01
2023-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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Buprenorphine Extended-Release Injection
Administered as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Sex: male or female.
3. Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.
4. Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD), or documented history of moderate to severe OUD and receiving/stabilized on medicine for opioid use disorder (MOUD).
5. Body mass index: ≥ 18.0 to ≤ 33.0 kg/m\^2.
6. New to treatment and seeking MOUD, or currently prescribed transmucosal (TM) buprenorphine (BUP) for OUD at the dose of 12 mg daily or can dose adjust to 12 mg daily.
7. Agree not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study.
Exclusion Criteria
2. Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.
3. Has target areas unsuitable for subcutaneous injections or evaluation of injections site (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study.
4. Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of SUBLOCADE or still recovering from prior such injury or surgery.
5. Known personal and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other medications that prolong the QT interval. Known family history of sudden unexplained death.
6. Currently taking (within the 30 days prior to signing the ICF) prescription or over-the-counter medications that are clinically relevant CYP 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals \[eg, ketoconazole\], macrolide antibiotics \[eg, erythromycin\]).
7. Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.
8. Has any active medical condition, or psychiatric illness, or social/legal situation (including court order requiring treatment for OUD), or organ disease, or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, or limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent.
9. Moderate or severe hepatic impairment (Child-Pugh B or C).
10. Has known allergy or hypersensitivity to BUP or any component of the ATRIGEL Delivery System.
11. Concurrent or has had prior treatment with any BUP long-acting injectable product (eg, SUBLOCADE) in the past 3 years prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.
12. Treatment with another investigational agent within 30 days prior to Screening or enrollment in another clinical study (except for an observational study).
13. Concurrent treatment with medications contraindicated for use with BUP as per local prescribing information.
14. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff or Indivior employee).
18 Years
65 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Director Clinical Development
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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Artemis Institute for Clinical Research
San Diego, California, United States
Research Centers of America
Hollywood, Florida, United States
Miami Lakes Medical Research
Miami Lakes, Florida, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Primary
Document Type: Statistical Analysis Plan: Addendum
Other Identifiers
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INDV-6000-405
Identifier Type: -
Identifier Source: org_study_id
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