- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704543
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults
Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in 4 different quadrants of the abdomen for treatment of opioid use disorder (OUD). Injection locations are rotated to minimize irritation. Having 1 or more alternate injection sites is desirable for patients who may be taking SUBLOCADE for extended durations, based upon clinical response.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Global Director Clinical Development
- Phone Number: (804) 594-4488
- Email: trialdisclosure@indivior.com
Study Locations
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California
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San Diego, California, United States, 92103
- Artemis Institute for Clinical Research
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Florida
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Hollywood, Florida, United States, 33024
- Research Centers of America
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Miami Lakes, Florida, United States, 33016
- Miami Lakes Medical Research
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Rivus Wellness and Research Institute
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Texas
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DeSoto, Texas, United States, 75115
- InSite Clinical Research, LLC
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Richardson, Texas, United States, 75080
- Pillar Clinical Research, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
- Sex: male or female.
- Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.
- 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).
- Body mass index: ≥ 18.0 to ≤ 33.0 kg/m^2.
- 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.
- Agree not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study.
Exclusion Criteria:
- Has current diagnosis, other than OUD, requiring chronic opioid treatment.
- Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.
- 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.
- 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.
- 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.
- 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]).
- 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.
- 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.
- Moderate or severe hepatic impairment (Child-Pugh B or C).
- Has known allergy or hypersensitivity to BUP or any component of the ATRIGEL Delivery System.
- 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.
- Treatment with another investigational agent within 30 days prior to Screening or enrollment in another clinical study (except for an observational study).
- Concurrent treatment with medications contraindicated for use with BUP as per local prescribing information.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Extended-release Buprenorphine: Abdomen
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
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Administered as a subcutaneous injection.
Other Names:
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Experimental: 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.
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Administered as a subcutaneous injection.
Other Names:
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Experimental: Extended-release Buprenorphine: Buttocks
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
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Administered as a subcutaneous injection.
Other Names:
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Experimental: Extended-release Buprenorphine: Thigh
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
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Administered as a subcutaneous injection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under the Concentration-time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Time Frame: 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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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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Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Time Frame: 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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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants with Treatment-emergent Adverse Events
Time Frame: 28 days
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28 days
|
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Number of Participants with Treatment-emergent Adverse Events Identified as Injection Site Reactions
Time Frame: 28 days
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28 days
|
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Number of Participants with Treatment-emergent Serious Adverse Events
Time Frame: 28 days
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28 days
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Injection Site Grading
Time Frame: Day 1 at 10 minutes and 2 hours post dosing
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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.
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Day 1 at 10 minutes and 2 hours post dosing
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Injection Site Pain
Time Frame: Day 1 at 1, 5, 10, 15, and 30 minutes post dosing
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Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.
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Day 1 at 1, 5, 10, 15, and 30 minutes post dosing
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Global Director Clinical Development, Indivior Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- INDV-6000-405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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