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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02651584
First received: December 30, 2015
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Opioid Use Disorders Drug: CAM2038 subcutaneous injection Drug: SL BPN tablets Drug: placebo subcutaneous (SC) injections Drug: SL placebo tablets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Braeburn Pharmaceuticals:

Primary Outcome Measures:
  • The primary outcome measure will be the response rate, denoted by response rate (Weeks 1-24). [ Time Frame: 24 weeks ]
    A responder is defined as a subject with at least 33% of urine technology 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:
  • Secondary efficacy endpoints will include response rate over 24 weeks of treatment for the following outcome measures: [ Time Frame: 24 weeks ]
    Percentage of urine samples negative for illicit opioids

  • Secondary efficacy endpoints will include response rate over 24 weeks of treatment for the following outcome measures [ Time Frame: 24 weeks ]
    Time to sustained abstinence of opioid use

  • 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 ]
    Percent of subjects remain in in the trial (retention rate)


Enrollment: 429
Study Start Date: December 2015
Study Completion Date: November 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: SL BPN tablets + placebo subcutaneous (SC) injections

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.

Drug: SL BPN tablets Drug: placebo subcutaneous (SC) injections
Experimental: Group 2: CAM2038 SC injections + SL placebo tablets

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.

Drug: CAM2038 subcutaneous injection Drug: SL placebo tablets

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) 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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02651584

  Show 36 Study Locations
Sponsors and Collaborators
Braeburn Pharmaceuticals
Investigators
Study Chair: Braeburn Pharmaceuticals Braeburn Pharmaceuticals
  More Information

Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651584     History of Changes
Other Study ID Numbers: HS-11-421
Study First Received: December 30, 2015
Last Updated: November 17, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 21, 2017