A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: sublingual buprenorphine tablets; Buprenorphine implant; placebo implants; sublingual placebo tablets
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to demonstrate maintenance of treatment efficacy when
      transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg
      or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.

      The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult
      outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must provide written informed consent prior to the conduct of any
             study-related procedures.

          2. Male or female, 18-65 years of age, inclusive.

          3. Primary diagnosis of opioid dependence (DSM-IV-TR).

          4. Subject is considered clinically stable by their treating healthcare provider and
             confirmed by the following:

               1. Subject must be on SL BPN treatment for at least 6 months.

               2. Subject must have been on a SL BPN dose of 8 mg or less daily for at least the
                  last 90 days prior to Screening.

               3. No positive urine toxicology results for illicit opioids in the last 90 days.

          5. Free from significant withdrawal symptoms (score of ≤ 5 on the Clinical Opiate
             Withdrawal Scale [COWS]), as measured at the Screening Visit.

          6. Female subjects of childbearing potential must be willing to use a reliable method of
             contraception during the entire study (Screening Visit to Follow-Up Visit).

        Exclusion Criteria:

          1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).

          2. Current diagnosis of chronic pain syndrome requiring chronic opioid treatment, or
             conditions associated with acute episodic flares that require opioid treatment.

          3. Pregnant or lactating or planning to become pregnant during the study.

          4. Hypersensitivity or allergy to ethylene vinyl acetate (EVA)-containing substances or
             naloxone.

          5. Recent scarring or tattoos on their upper arms, or a history of keloid scarring.

          6. Requires current use of agents metabolized through CYP 3A4 such as azole antifungals
             (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease
             inhibitors (e.g., ritonavir, indinavir, and saquinavir).

          7. History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy
             such as warfarin.

          8. Current DSM-IV-TR diagnosis for substance dependence on any other psychoactive
             substances other than opioids or nicotine (e.g., alcohol, cocaine).

          9. Significant symptoms or other factors which in the opinion of the Investigator would
             preclude compliance with the protocol, subject safety, adequate cooperation in the
             study, or obtaining informed consent.

         10. Current medical conditions such as severe respiratory insufficiency that may prevent
             the subject from safely participating in study.

         11. Any pending legal action that could prohibit participation or compliance in the study.

         12. Exposure to any investigational drug within the 8 weeks prior to Screening.

         13. Aspartate aminotransferase levels ≥3 X the upper limit of normal, alanine
             aminotransferase 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.

         14. Clinically significant low platelet count on the Screening laboratory assessments,
             according to the Investigator.