Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Condition: Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Intervention: CAM2038 SC injection; SL BPN/NX tabs; placebo SC injections; SL placebo tablets
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 428.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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.