Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
Condition: Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall goal of this research project is to test a newly developed behavioral therapy to
      enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone
      maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:

        1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of
           relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE)
           Therapy.

        2. Lifetime history of depression will predict dysphoria and non-compliance with
           naltrexone.
    

Detailed description: 
      Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence,
      but has not been successful clinically because of at least three problems: 1) The transition
      from opiate to naltrexone precipitates opiate withdrawal unless the patient has been off any
      opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone
      doses and begin to experience effects from illicit opiates and become re-addicted, at which
      point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may
      produce dysphoria in some patients. The proposed research study will offer opiate dependent
      patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using
      buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification
      at an outside unit, they will be assessed for opiate dependence using the naloxone challenge.
      Patients will then be either discharged or entered directly into outpatient treatment where
      they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy"
      (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network
      Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate
      outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the
      family and social network to reinforce naltrexone compliance and abstinence. In this current
      investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients
      are stratified at baseline by presence or absence of lifetime depressive disorder, which the
      investigators hypothesize will predict dysphoria on naltrexone and non-compliance. Patients
      are discharged from the hospital, or entered directly, into outpatient treatment at STARS at
      NYSPI to receive both counseling and Naltrexone, 50 mg per day.
    

Intervention name(s): Naltrexone; Behavioral Naltrexone Therapy (BNT); Compliance Enhancement (CE)
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): 50mg of oral naltrexone daily; a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy; a controlled therapy intended to simulate outpatient psychiatric care.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment