Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

Phase 4

Completed

• Conditions: Opioid Use Disorder
• Interventions: Drug: Buprenorphine Extended-Release Injection

• Registration Number: NCT05704543
• Lead Sponsor: Indivior Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-03-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Results First Submitted: 2024-10-28
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Results First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
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

1. Has current diagnosis, other than OUD, requiring chronic opioid treatment.
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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended-release Buprenorphine: Upper Arm	Buprenorphine Extended-Release Injection	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Extended-release Buprenorphine: Buttocks	Buprenorphine Extended-Release Injection	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Extended-release Buprenorphine: Thigh	Buprenorphine Extended-Release Injection	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Extended-release Buprenorphine: Abdomen	Buprenorphine Extended-Release Injection	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Injection Site Pain	Day 1 at 1, 5, 10, 15, and 30 minutes post dosing	Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.
Injection Site Grading	Day 1 at 10 minutes and 2 hours post dosing	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.
Participants With Treatment-emergent Adverse Events	28 days
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions	28 days
Number of Participants With Treatment-emergent Serious Adverse Events	28 days

Trial Locations

Locations (6)

Miami Lakes Medical Research; 🇺🇸 Miami Lakes, Florida, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Research Centers of America; 🇺🇸 Hollywood, Florida, United States

InSite Clinical Research, LLC; 🇺🇸 DeSoto, Texas, United States

Pillar Clinical Research, LLC; 🇺🇸 Richardson, Texas, United States

Rivus Wellness and Research Institute; 🇺🇸 Oklahoma City, Oklahoma, United States