Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder
1 other identifier
interventional
428
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Shorter than P25 for phase_3
36 active sites
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
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
August 22, 2019
CompletedAugust 22, 2019
August 1, 2018
10 months
December 30, 2015
August 3, 2018
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate, Denoted by Response Rate (Weeks 1-24).
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
24 weeks
Secondary Outcomes (3)
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
24 weeks
Number of Subjects With Sustained Abstinence of Opioid Use
24 weeks
Number of Subjects Remaining in the Study (Retention Rate)
24 weeks
Study Arms (2)
SL BPN/NX tabs + placebo SC injections
EXPERIMENTALSL 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).
CAM2038 SC injections + SL placebo tabs
EXPERIMENTALCAM2038 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
Interventions
Eligibility Criteria
You may qualify if:
- Subject must provide written informed consent prior to the conduct of any trial-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Diagnosis of moderate or severe opioid use disorder as described (DSM-V).
- Voluntarily seeking treatment for opioid use disorder.
- Have not received medication-assisted treatment for opioid use disorder within 60 days prior to randomization.
- Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.
- 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)
You may not qualify if:
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain requiring opioids for treatment.
- 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).
- Pregnant or lactating or planning to become pregnant during the trial.
- Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid antagonists, or excipients of CAM2038 or SL BPN.
- 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).
- 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.
- 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).
- Any pending legal action that could prohibit participation or compliance in the trial.
- Exposure to any investigational drug within the 4 weeks prior to Screening.
- 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.
- 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.
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Haleyville Clinical Research LLC
Haleyville, Alabama, 35565, United States
Boyett Health Services Inc
Hamilton, Alabama, 35570, United States
Synergy East
Lemon Grove, California, 91945, United States
North County Clinical Research
Oceanside, California, 92056, United States
Asclepes Research
Panorama City, California, 91402, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Care Practice
San Francisco, California, 94708, United States
Synergist Research
West Hollywood, California, 90046, United States
Dr Vijapura and Associates
Jacksonville, Florida, 32256, United States
Innovative Clinical Research Inc
Lauderhill, Florida, 33319, United States
TRY Research
Maitland, Florida, 32751, United States
Tellus Clinical Research, Inc.
Miami, Florida, 33173, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40508, United States
Stanley Street Treatment and Resources Inc
Fall River, Massachusetts, 02720, United States
Novex Clinical Research
New Bedford, Massachusetts, 02740, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
St. Louis Clinical Trials
St Louis, Missouri, 63141, United States
Wellness and Research Center
Belvidere, New Jersey, 07823, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
STARS/Columbia University
New York, New York, 10019, United States
Neuro-Behavioral Clinical Research Center
Canton, Ohio, 44718, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
North Star Medical Research
Middleburg Heights, Ohio, 44130, United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112, United States
Frost Medical Group
Conshohocken, Pennsylvania, 19428, United States
The University of Pennsylvania Health System Treatment Research Center
Philadelphia, Pennsylvania, 19104, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Carolina Clinical Trials, Inc
Charleston, South Carolina, 29407, United States
InSite Clinical Research
Dallas, Texas, 75115, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
University of Vermont
Burlington, Vermont, 05401, United States
Swedish Health Services
Seattle, Washington, 98107, United States
Related Publications (3)
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.
PMID: 39629836DERIVEDNunes 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.
PMID: 38916892DERIVEDLofwall 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.
PMID: 29799968DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sonnie Kim
- Organization
- Braeburn Pharmaceuticals
Study Officials
- STUDY CHAIR
Braeburn Pharmaceuticals
Braeburn Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 11, 2016
Study Start
December 1, 2015
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
August 22, 2019
Results First Posted
August 22, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share