Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Condition: Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine soluble film; Buprenorphine/naloxone film strip; Placebo
Intervention description: Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.; Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.; Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid dependence; Opioid withdrawal symptoms

Summary:

      The purpose of this study is to compare the presence, degree, time course and profile of
      opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine
      or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome
      measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal
      Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate
      an opioid withdrawal syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must:

          -  Provide written informed consent.

          -  Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of
             opioid dependence.

          -  Be male or female, 18 to 65 years of age, inclusive.

          -  If female, have a negative pregnancy test during screening and agree to use an
             acceptable method of birth control.

        Exclusion Criteria:

        Subjects must not:

          -  Have participated in an experimental drug or device study within the last 30 days.

          -  Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid
             partial agonist, or opioid antagonist treatment.

          -  If female, be breast feeding or lactating.

          -  Have any medical condition that in the opinion of the physician investigator would
             preclude the subject from completing the study.

          -  Have any clinically significant non-substance use psychiatric disorder (e.g.,
             schizophrenia).

          -  Have current suicidal ideation.

          -  Have a Mini Mental Status Exam score less than 24.

          -  Have physical dependence on alcohol.

          -  Have physical dependence on sedative-hypnotics.

          -  Have active aphthous stomatitis.

          -  Have active oral herpes.

          -  Need on-going prescription medications that interact with the P450 3A4 (a member of
             the cytochrome P450 superfamily of enzymes) system.