Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Naltrexone

Criteria

Inclusion:

1. Adult, aged 18-60.

2. Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and further by a positive naloxone challenge test if the diagnosis is unclear.

3. Able to give informed consent.

4. At least one significant other is willing to be interviewed for possible participation in the treatment.

Exclusion:

1. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.

2. Active medical illness which might make participation hazardous, such as untreated hypertension, unstable cardiovascular disease, acute hepatitis with SGOT or SGPT > 2-3 times normal, unstable diabetes, AIDS dementia.

3. Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk of 1 or more suicide attempts within the past year.

4. History of allergic reaction to naloxone, naltrexone, buprenorphine, clonidine, or clonazepam.

5. Currently prescribed or regularly taking opiates for chronic pain or medical illness.

6. Current participation in another intensive treatment program or currently prescribed psychotropic medications in the last 30 days.

7. Current participation in a Methadone Maintenance program and/or regular and/or Dependent use of street methadone.

8. Opiate-dependent individuals who are seeking methadone maintenance treatment.

9. History of accidental drug overdose in the last three years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.