NCT05704543

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

January 19, 2023

Results QC Date

October 28, 2024

Last Update Submit

December 18, 2024

Conditions

Opioid Use Disorder

Keywords

medicine for opioid use disorder (MOUD)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

  • Injection Site Grading

    Day 1 at 10 minutes and 2 hours post dosing

  • Injection Site Pain

    Day 1 at 1, 5, 10, 15, and 30 minutes post dosing

Study Arms (4)

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.

Drug: Buprenorphine Extended-Release Injection

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.

Drug: Buprenorphine Extended-Release Injection

Extended-release Buprenorphine: Buttocks

EXPERIMENTAL

Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.

Drug: Buprenorphine Extended-Release Injection

Extended-release Buprenorphine: Thigh

EXPERIMENTAL

Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.

Drug: Buprenorphine Extended-Release Injection

Interventions

Buprenorphine Extended-Release InjectionDRUG

Administered as a subcutaneous injection.

Also known as: SUBLOCADE®
Extended-release Buprenorphine: AbdomenExtended-release Buprenorphine: ButtocksExtended-release Buprenorphine: ThighExtended-release Buprenorphine: Upper Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Miami Lakes Medical Research

Miami Lakes, Florida, 33016, United States

Location

Rivus Wellness and Research Institute

Oklahoma City, Oklahoma, 73112, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

Related Publications (1)

  • 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.

    PMID: 39543001DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Global Director Clinical Development
Organization
Indivior Inc.
trialdisclosure@indivior.com
(804) 594-4488

Study Officials

  • Global Director Clinical Development

    Indivior Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

March 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

January 7, 2025

Results First Posted

January 7, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(6)