Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
Condition: Opiate 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 the efficacy of a newly developed
      therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone
      maintenance and long-term abstinence for individuals with heroin dependence. This study
      includes free detox and outpatient treatment for opioid dependence that includes medication
      and a behavioral intervention.
    

Detailed description: 
      The goal of this Stage II project is to test the efficacy of a new combination of behavioral
      therapy with oral naltrexone maintenance for the treatment of heroin addiction, and to test a
      new long-acting depot parenteral formulation of naltrexone in initiating treatment.

        1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of
           relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy.
           Hypotheses:

        2. Injections of depot naltrexone will reduce early attrition, improve initial
           stabilization on oral naltrexone, and improve long-term outcome, particularly when
           combined with Behavioral Naltrexone Therapy.

        3. Patients who exhibit escalating levels of commitment language strength throughout one
           early session of BNT will remain in treatment longer, will take more doses of
           naltrexone, and will provide a higher percentage of opiate-free urines.

        4. Increased commitment language strength on the part of the SO monitor will contribute
           independently to the outcome of the identified patient, when controlling for patient
           level commitment.

      A critical objective of this current proposal is to improve retention, particularly in the
      initial weeks of treatment. Preliminary work with a new depot formulation of naltrexone was
      conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and
      provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a
      single injection. By removing the option of stopping naltrexone to sample heroin, a common
      mode of relapse, we hope to prevent early attrition and fully expose all patients to the
      behavioral regimen of BNT, intended to shape strong compliance with oral naltrexone and
      motivation for abstinence and lifestyle change.

      160 heroin-dependent individuals seeking treatment will be recruited at PI (STARS) or
      referred from other sites (e.g., private physician; other detoxification programs).
      Prospective patients will be offered hospitalization for detoxification for rapid transition
      to naltrexone followed by outpatient naltrexone maintenance and counseling for six months.
      All enrolled participants will be encouraged to return for follow-up assessment visits at
      one, three, and six months beyond the completion of their participation for research
      purposes.

      Patients will be randomly assigned to either the newly developed BNT or Compliance
      Enhancement Therapy (CET), a manual-guided approach developed by Carroll and O'Malley at Yale
      University as a control condition for psychotherapy studies with substance dependent
      patients. Patients will also be randomly assigned to receive either active or placebo
      injections of depot naltrexone prior to discharge from the detoxification. Therefore, there
      will be four treatment conditions with 40 participants per condition. These four conditions
      include: 1) BNT plus two doses of depot naltrexone prior to hospital discharge; 2) BNT plus
      two placebo injections; 3) Compliance Enhancement (CE), simulating standard treatment with
      oral naltrexone plus two depot naltrexone injections; and 4) CE plus two placebo injections.
    

Intervention name(s): depot naltrexone; Compliance enhancement (CE); BNT
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): long-acting depot parenteral formulation of naltrexone; Compliance enhancement (CE), simulating standard treatment with oral naltrexone; behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opiate dependence; heroin dependence; naltrexone; cognitive behavioral therapy