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

Opioid Use Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651584
• Other study ID #: HS-11-421
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2018
• Source: Braeburn Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• CAM2038 SC injection

• SL BPN/NX tabs

• placebo SC injections

• SL placebo tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Braeburn Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids	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)	24 weeks
Secondary	Number of Subjects With Sustained Abstinence of Opioid Use	Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038	24 weeks
Secondary	Number of Subjects Remaining in the Study (Retention Rate)	Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038	24 weeks