Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: very low dose naltrexone; extended release naltrexone; buprenorphine/naloxone
Intervention description: On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.; On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.; On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Intervention MeSH terms: Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid Addiction; Addiction; Drug Dependence

Summary:

      The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment
      to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).
      The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding
      the treatment acceptable and showing minimal withdrawal discomfort.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six
             months duration, supported by a positive urine for opiates and a positive naloxone
             challenge test if the diagnosis is unclear.

          2. Individuals must be capable of giving informed consent and capable of complying with
             study procedures.

          3. Participants will be asked to provide locator information including the address and
             telephone number of a non-drug abusing relative or friend who can reach the
             participant in emergencies.

        Exclusion Criteria:

          1. Individuals currently prescribed or regularly taking opiates for chronic pain or
             medical illness.

          2. Individuals regularly using licit or illicit methadone or BUP.

          3. Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic
             disorders, or psychiatric disorder (other than substance abuse) requiring
             intervention.

          4. Individuals who are medically unstable, or have liver enzyme function tests greater
             than two times normal.

          5. Individuals with current suicidal risk or 1 or more suicide attempts within the past
             year.

          6. History of accidental drug overdose in the last three years or any other significant
             history of overdose following detoxification, defined as an episode of opioid-induced
             unconsciousness or incapacitation.

          7. Nursing/pregnant women, or failure in a sexually active man or woman to use adequate
             contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or
             condoms)

          8. Individuals who are dependent on any other drugs (excluding nicotine)

          9. Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.

         10. Individuals who are court-mandated to treatment.

         11. Individuals who have a current or pending legal status, or any other condition that
             would make them unlikely to be available for the duration of the study.