A Multiple Dose Opioid Challenge Study
Condition: Moderate or Severe Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: CAM2038
Intervention description: CAM2038 subcutaneous injection
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and
      duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in
      patients with moderate or severe opioid use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient had to provide written informed consent prior to the conduct of any
             study-related procedures.

          2. Male or female, 18-55 years of age, inclusive.

          3. Patients with a diagnosis of moderate or severe opioid use disorder (DSM-V) who were
             physically dependent on intravenous (IV) or insufflated opioids, and who were willing
             to undergo short-term BPN treatment.

          4. Self-reported opioid-use of a minimum of 21 days in the 30 days prior to Screening.

          5. Positive UDS for opioids at Screening or at check-in. If UDS was not positive,
             patients had to present with physical signs of withdrawal, as determined by the
             Investigator. The Investigator may have administered a naloxone challenge, in order to
             confirm opioid dependence at the Investigator's discretion.

          6. Female patients of childbearing potential had to be willing to use a reliable method
             of contraception during the entire study (Screening Visit to Follow-up Phone Call).

          7. Female patients of non-childbearing potential were surgically sterile (i.e., had
             undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a
             menopausal state (at least 1 year without menses), as confirmed by follicle
             stimulating hormone (FSH) levels.

          8. Male patients with female partners of childbearing potential had to agree to use a
             reliable method of contraception from Screening Visit through at least 3 months after
             the last dose of study drug. Male patients also must have agreed not to donate sperm
             during the study through at least 3 months after the last dose of study drug.

          9. Were willing and able to comply with the study requirements (including blood
             sampling), complete study assessments, visit the clinic, and remain confined in the
             CRU for up to 25 consecutive days.

        Exclusion Criteria:

          1. History or presence of any clinically significant psychiatric, endocrine, hematologic,
             hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal,
             or other major disease or illness at Screening, which in the opinion of the
             Investigator would have jeopardized the safety of the patient or the validity of the
             study results.

          2. Opioid-dependent patients who were actively seeking treatment for their moderate to
             severe opioid use disorder.

          3. Patients with positive UDS for BPN, barbiturates, or methadone or breath alcohol on
             the day of check-in to the CRU.

          4. 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 the upper limit of normal on the
             Screening laboratory assessments and at inpatient check-in, or other clinically
             significant laboratory abnormalities, which in the opinion of the Investigator may
             have prevented the patient from safely participating in study.

          5. Any clinically significant abnormality on the basis of medical history, vital signs,
             physical examination, 12-lead electrocardiogram ([ECG], QTcF ≥450 msec for males or
             ≥470 msec for females), and laboratory evaluation (including hematology, clinical
             chemistry, urinalysis, and serology [optional]) at Screening, in the opinion of the
             Investigator.

          6. Significant symptoms, medical conditions, or other circumstances which, in the opinion
             of the Investigator, would have precluded compliance with the protocol, adequate
             cooperation in the study or obtaining informed consent, or may have prevented the
             patient from safely participating in study (including, but not limited to, the risks
             described as precautions, warnings, and contraindications in the current version of
             the Investigator's Brochure for CAM2038).

          7. Patients were carefully screened to exclude individuals presenting with a clinically
             significant history of seizure disorders, history of asthma or other respiratory
             disorders, head injury, hypertension, or personal history of cardiovascular disease or
             clinically significant ECG abnormalities.

          8. Current diagnosis of Acquired Immune Deficiency Syndrome.

          9. Current diagnosis of chronic pain requiring opioids for treatment.

         10. Patients who met the criteria for a diagnosis of moderate or severe substance use
             disorder according to DSM-V criteria for any other substances other than opioids,
             caffeine, or tobacco.

         11. Pregnant or lactating, or planned to become pregnant during the study.

         12. Clinically significant history of or current evidence of suicidal ideation or active
             suicidal behavior as based on the Columbia-Suicide Severity Rating Scale (C-SSRS;
             grade 4 or 5).

         13. Hypersensitivity or allergy to BPN or other opioids or excipients of CAM2038.

         14. Intolerance to venipuncture and/or difficulty with venous access, as per the judgment
             of the Investigator/research staff.

         15. Patient was using an investigational drug or monoamine oxidase inhibitor or had used
             such within the last 30 days (or 5 times the half-life of the drug, if known and
             longer) prior to first drug administration in the Qualification Phase (i.e., IR
             morphine sulfate).

         16. Required current use of agents that were 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).

         17. If the patient was currently on probation or had any pending legal action that could
             have prohibited participation or compliance in the study.

         18. A patient who, in the opinion of the Investigator, was considered unsuitable or
             unlikely to comply with the study protocol for any reason.