Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Condition: Opiate Dependence; Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the
      new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide
      initial clinical experience with the new Depot-BNT treatment model, while providing a
      rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best
      behavioral platform for oral naltrexone (BNT).

      The following aims will be addressed:

      Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug
      use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with
      oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key
      secondary outcomes including dysphoria, HIV risk behavior, and social functioning.

      Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,
      in order to optimize Depot-BNT prior to further testing.
    

Detailed description: 
      The clinical trial now proposed will provide an initial test of the feasibility and efficacy
      of the newly adapted version of Behavioral Naltrexone Therapy for Depot Naltrexone
      (Depot-BNT). Treatment-seeking opiate-dependent patients will be admitted for inpatient
      detoxification and induction onto oral naltrexone. Those who are successfully inducted will
      be randomly assigned for a six month trial to one of two conditions: 1) Behavioral Naltrexone
      Therapy for Depot Naltrexone (Depot-BNT) (N = 30), with the first dose of depot naltrexone
      administered prior to discharge from hospital with monthly doses thereafter; or 2) Behavioral
      Naltrexone Therapy as previously developed for promoting compliance with daily oral
      naltrexone (BNT-Oral) (N = 30). All patients in both groups will be asked to attend twice
      weekly outpatient therapy sessions over a six month course. This design will provide a test
      of whether Depot-BNT produces superior treatment retention and drug use outcome in comparison
      to our established behavioral platform for oral naltrexone, while providing experience upon
      which to base revisions of Depot-BNT prior to embarking upon further Stage 2 testing.
      Treatment will take place at the same sites as for our prior studies: (1) the General
      Clinical Research Unit (GCRU) of New York State Psychiatric Institute (NYSPI) and (2) the
      Substance Treatment and Research Service (STARS) of the Division on Substance Abuse at NYSPI.
    

Intervention name(s): depot naltrexone; Oral Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).; For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
Other intervention name(s): Vivitrol; Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opiate Dependence; Heroin Dependence; Naltrexone