Clinical trial NCT02651584: Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorders
Lead sponsor: Braeburn Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response Rate, Denoted by Response Rate (Weeks 1-24).
timeFrame: 24 weeks
Secondary outcomes:
measure: Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
timeFrame: 24 weeks
measure: Number of Subjects With Sustained Abstinence of Opioid Use
timeFrame: 24 weeks
measure: Number of Subjects Remaining in the Study (Retention Rate)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Haleyville
country: United States
facility: Haleyville Clinical Research LLC
state: Alabama
city: Hamilton
country: United States
facility: Boyett Health Services Inc
state: Alabama
city: Lemon Grove
country: United States
facility: Synergy East
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Panorama City
country: United States
facility: Asclepes Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Francisco
country: United States
facility: Care Practice
state: California
city: West Hollywood
country: United States
facility: Synergist Research
state: California
city: Jacksonville
country: United States
facility: Dr Vijapura and Associates
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research Inc
state: Florida
city: Maitland
country: United States
facility: TRY Research
state: Florida
city: Miami
country: United States
facility: Tellus Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources Inc
state: Massachusetts
city: New Bedford
country: United States
facility: Novex Clinical Research
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Belvidere
country: United States
facility: Wellness and Research Center
state: New Jersey
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: STARS/Columbia University
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Rivus Wellness & Research Institute
state: Oklahoma
city: Conshohocken
country: United States
facility: Frost Medical Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: The University of Pennsylvania Health System Treatment Research Center
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc
state: South Carolina
city: Dallas
country: United States
facility: InSite Clinical Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
Study officials:
affiliation: Braeburn Pharmaceuticals
name: Braeburn Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.