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

Opioid Use Disorder Clinical Trial

Official title:

A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05704543
• Other study ID #: INDV-6000-405
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2024
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine Extended-Release Injection
Administered as a subcutaneous injection.

Locations

Country	Name	City	State
United States	InSite Clinical Research, LLC	DeSoto	Texas
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	Pillar Clinical Research, LLC	Richardson	Texas
United States	Artemis Institute for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the 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
Primary	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	Participants with Treatment-emergent Adverse Events		28 days
Secondary	Number of Participants with Treatment-emergent Adverse Events Identified as Injection Site Reactions		28 days
Secondary	Number of Participants with Treatment-emergent Serious Adverse Events		28 days
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.	Day 1 at 10 minutes and 2 hours post dosing
Secondary	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