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

Phase 3

Completed

Conditions: Opioid Use Disorders

Interventions: Drug: CAM2038 SC injection
Drug: SL BPN/NX tabs
Drug: placebo SC injections
Drug: SL placebo tablets

Registration Number: NCT02651584

Lead Sponsor: Braeburn Pharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 428

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAM2038 SC injections + SL placebo tabs	CAM2038 SC injection	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
SL BPN/NX tabs + placebo SC injections	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).
SL BPN/NX tabs + placebo SC injections	SL BPN/NX tabs	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).
CAM2038 SC injections + SL placebo tabs	SL placebo tablets	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

Primary Outcome Measures

Name	Time	Method
Response Rate, Denoted by Response Rate (Weeks 1-24).	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Sustained Abstinence of Opioid Use	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)	24 weeks	Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids	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)

Trial Locations

Locations (36): Innovative Clinical Research Inc
🇺🇸
Lauderhill, Florida, United States
Dr Vijapura and Associates
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Jacksonville, Florida, United States
TRY Research
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Maitland, Florida, United States
Scientific Clinical Research, Inc.
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North Miami, Florida, United States
Novex Clinical Research
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New Bedford, Massachusetts, United States
Care Practice
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San Francisco, California, United States
Aspen Clinical Research
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Orem, Utah, United States
STARS/Columbia University
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New York, New York, United States
Haleyville Clinical Research LLC
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Haleyville, Alabama, United States
Parkway Medical Center
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Birmingham, Alabama, United States
Rivus Wellness & Research Institute
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Oklahoma City, Oklahoma, United States
Carolina Clinical Trials, Inc
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Charleston, South Carolina, United States
Synergy East
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Lemon Grove, California, United States
North Star Medical Research
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Middleburg Heights, Ohio, United States
Stanley Street Treatment and Resources Inc
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Fall River, Massachusetts, United States
Neuro-Behavioral Clinical Research Center
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Canton, Ohio, United States
InSite Clinical Research
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Dallas, Texas, United States
University of Vermont
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Burlington, Vermont, United States
Swedish Health Services
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Seattle, Washington, United States
Comprehensive Clinical Research
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Berlin, New Jersey, United States
The University of Pennsylvania Health System Treatment Research Center
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Philadelphia, Pennsylvania, United States
Artemis Institute for Clinical Research
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San Diego, California, United States
Boyett Health Services Inc
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Hamilton, Alabama, United States
Tellus Clinical Research, Inc.
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Miami, Florida, United States
Asclepes Research
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Panorama City, California, United States
North County Clinical Research
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Oceanside, California, United States
Professional Research Network of Kansas, LLC
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Wichita, Kansas, United States
University of Kentucky Medical Center
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Lexington, Kentucky, United States
Precise Research Centers
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Flowood, Mississippi, United States
St. Louis Clinical Trials
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Saint Louis, Missouri, United States
PsychCare Consultants Research
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Saint Louis, Missouri, United States
Midwest Clinical Research Center
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Dayton, Ohio, United States
Synergist Research
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West Hollywood, California, United States
Wellness and Research Center
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Belvidere, New Jersey, United States
Frost Medical Group
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Conshohocken, Pennsylvania, United States
Lincoln Research
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Lincoln, Rhode Island, United States