Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence

NCT ID: NCT02651584

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-11-30

Brief Summary

Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.

Detailed Description

This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits), and Follow-up.

Approximately 380 subjects (190 subjects per arm) will be randomized.

Conditions

Opioid Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SL BPN/NX tabs + placebo SC injections

SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.

CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).

Group Type: EXPERIMENTAL

SL BPN/NX tabs

Intervention Type: DRUG

placebo SC injections

Intervention Type: DRUG

CAM2038 SC injections + SL placebo tabs

CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 or 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).

CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).

SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily

Group Type: EXPERIMENTAL

CAM2038 SC injection

Intervention Type: DRUG

SL placebo tablets

Intervention Type: DRUG

Interventions

CAM2038 SC injection

Intervention Type: DRUG

SL BPN/NX tabs

Intervention Type: DRUG

placebo SC injections

Intervention Type: DRUG

SL placebo tablets

Intervention Type: DRUG

Other Intervention Names

Buprenorphine injection; Suboxone; placebo; placebo

Eligibility Criteria

Inclusion Criteria

1. Subject must provide written informed consent prior to the conduct of any trial-related procedures.

2. Male or female, 18-65 years of age, inclusive.

3. Diagnosis of moderate or severe opioid use disorder as described (DSM-V).

4. Voluntarily seeking treatment for opioid use disorder.

5. Have not received medication-assisted treatment for opioid use disorder within 60 days prior to randomization.

6. Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.

7. Male or Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire trial (Screening visit to Follow-up visit)

Exclusion Criteria

1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).

2. Current diagnosis of chronic pain requiring opioids for treatment.

3. Current DSM-V diagnosis of moderate to severe substance use disorder on any other psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol, cocaine, sedatives).

4. Pregnant or lactating or planning to become pregnant during the trial.

5. Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid antagonists, or excipients of CAM2038 or SL BPN.

6. Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).

7. Subjects with active signs or symptoms of hepatitis and requiring treatment. Subjects with no acute signs of inflammation, and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.

8. Recent history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes" responses to questions 4 or 5).

9. Any pending legal action that could prohibit participation or compliance in the trial.

10. Exposure to any investigational drug within the 4 weeks prior to Screening.

11. Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF >470 in females at screening.

12. Aspartate aminotransferase (AST) levels >3 X the upper limit of normal, alanine aminotransferase (ALT) levels >3 X the upper limit of normal, total bilirubin >1.5 X the upper limit of normal, or creatinine >1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in trial.

13. Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the trial or obtaining informed consent, or may prevent the subject from safely participating in trial (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for CAM2038).

14. Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other trials under the direction of the Investigator or trial site, or is a family member of an employee or of the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braeburn Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Braeburn Pharmaceuticals

Role: STUDY_CHAIR

Braeburn Pharmaceuticals

Locations

Parkway Medical Center

Birmingham, Alabama, United States

Haleyville Clinical Research LLC

Haleyville, Alabama, United States

Boyett Health Services Inc

Hamilton, Alabama, United States

Synergy East

Lemon Grove, California, United States

North County Clinical Research

Oceanside, California, United States

Asclepes Research

Panorama City, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Care Practice

San Francisco, California, United States

Synergist Research

West Hollywood, California, United States

Dr Vijapura and Associates

Jacksonville, Florida, United States

Innovative Clinical Research Inc

Lauderhill, Florida, United States

TRY Research

Maitland, Florida, United States

Tellus Clinical Research, Inc.

Miami, Florida, United States

Scientific Clinical Research, Inc.

North Miami, Florida, United States

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Stanley Street Treatment and Resources Inc

Fall River, Massachusetts, United States

Novex Clinical Research

New Bedford, Massachusetts, United States

Precise Research Centers

Flowood, Mississippi, United States

PsychCare Consultants Research

St Louis, Missouri, United States

St. Louis Clinical Trials

St Louis, Missouri, United States

Wellness and Research Center

Belvidere, New Jersey, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

STARS/Columbia University

New York, New York, United States

Neuro-Behavioral Clinical Research Center

Canton, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, United States

Frost Medical Group

Conshohocken, Pennsylvania, United States

The University of Pennsylvania Health System Treatment Research Center

Philadelphia, Pennsylvania, United States

Lincoln Research

Lincoln, Rhode Island, United States

Carolina Clinical Trials, Inc

Charleston, South Carolina, United States

InSite Clinical Research

Dallas, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

University of Vermont

Burlington, Vermont, United States

Swedish Health Services

Seattle, Washington, United States

Countries

United States

References

Peterson S, Nunes EV, Lofwall MR, Walsh SL, Tiberg F. Exploring Opioid Use Disorder Outcomes by Quantitative Urinalysis: Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. J Addict Med. 2025 May-Jun 01;19(3):260-267. doi: 10.1097/ADM.0000000000001405. Epub 2024 Dec 4.

Reference Type: DERIVED

PMID: 39629836 (View on PubMed)

Nunes EV, Comer SD, Lofwall MR, Walsh SL, Peterson S, Tiberg F, Hjelmstrom P, Budilovsky-Kelley NR. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417377. doi: 10.1001/jamanetworkopen.2024.17377.

Reference Type: DERIVED

PMID: 38916892 (View on PubMed)

Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.

Reference Type: DERIVED

PMID: 29799968 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

HS-11-421

Identifier Type: -

Identifier Source: org_study_id