Overview

This trial has been completed.

Condition opioid use disorders
Treatments cam2038 subcutaneous injection, sl bpn tablets, placebo subcutaneous (sc) injections, sl placebo tablets
Phase phase 3
Sponsor Braeburn Pharmaceuticals
Start date December 2015
End date October 2016
Trial size 429 participants
Trial identifier NCT02651584, HS-11-421

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) in initiation and maintenance treatment with BPN.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
SL BPN: 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). Following randomization, subjects will undergo initiation of BPN with either SL BPN or SC CAM2038 q1w and participate in weekly visits for 12 weeks (Phase 1). After Week 12, subjects will be transitioned to Phase 2 with monthly visits. During Phase 2, subjects in Group 1 will continue treatment with monthly dispensing of daily SL BPN treatment and monthly placebo SC injections, and subjects in Group 2 (receiving CAM2038 q1w) will be transferred to monthly injections of CAM2038 q4w and monthly dispensing of daily SL placebo.
sl bpn tablets
placebo subcutaneous (sc) injections
(Experimental)
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 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 Following randomization, subjects will undergo initiation of BPN with either SL BPN or SC CAM2038 q1w and participate in weekly visits for 12 weeks (Phase 1). After Week 12, subjects will be transitioned to Phase 2 with monthly visits. During Phase 2, subjects in Group 1 will continue treatment with monthly dispensing of daily SL BPN treatment and monthly placebo SC injections, and subjects in Group 2 (receiving CAM2038 q1w) will be transferred to monthly injections of CAM2038 q4w and monthly dispensing of daily SL placebo.
cam2038 subcutaneous injection
sl placebo tablets

Primary Outcomes

Measure
The primary outcome measure will be the response rate, denoted by response rate (Weeks 1-24).
time frame: 24 weeks

Secondary Outcomes

Measure
Secondary efficacy endpoints will include response rate over 24 weeks of treatment for the following outcome measures:
time frame: 24 weeks
Secondary efficacy endpoints will include response rate over 24 weeks of treatment for the following outcome measures
time frame: 24 weeks
Secondary safety endpoints will be measured by clinical laboratory parameters, electrocardiogram, physical, and injection site examinations, concomitant medications, vital signs and C-SSRS.
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 (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. 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 for 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. Active hepatitis. Subjects with no significant viral load, 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.

Additional Information

Official title 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
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) 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Braeburn Pharmaceuticals.