Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
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|ClinicalTrials.gov Identifier: NCT02651584|
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorders||Drug: CAM2038 SC injection Drug: SL BPN/NX tabs Drug: placebo SC injections Drug: SL placebo tablets||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
Experimental: 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).
Drug: SL BPN/NX tabs
Other Name: Suboxone
Drug: placebo SC injections
Other Name: placebo
Experimental: 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
Drug: CAM2038 SC injection
Other Name: Buprenorphine injection
Drug: SL placebo tablets
Other Name: placebo
- Response Rate, Denoted by Response Rate (Weeks 1-24). [ Time Frame: 24 weeks ]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.
- Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids [ Time Frame: 24 weeks ]Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)
- Number of Subjects With Sustained Abstinence of Opioid Use [ Time Frame: 24 weeks ]Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038
- Number of Subjects Remaining in the Study (Retention Rate) [ Time Frame: 24 weeks ]Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651584
|Study Chair:||Braeburn Pharmaceuticals||Braeburn Pharmaceuticals|