Opiate Dependence Clinical Trial
Official title:
Study Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
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.
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conducted (Comer et al, 1999, unpublished data), showing that it is well tolerated and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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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