Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

1. Adult, aged 18-60. Clinical Interview.

2. Meets DSM-IV criteria for current opiate dependence disorder, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.

Clinical and SCID interview. Urine toxicology. Naloxone Challenge (see Procedures) Communication with former treatment provider.

3. Able to give informed consent. Clinical interview and mental status exam

4. There must be one qualified significant other who is willing to be interviewed and participate in program in order for a subject to be included in the study.

Clinical interview, and statement by significant other.

Exclusion Criteria:

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

Clinical Interview, physical examination, serum pregnancy test

2. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2-3 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).

Clinical Interview, physical examination, laboratory (Chem-20, CBC, urinalysis), ECG

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 or 1 or more suicide attempts within the past year.

Clinical and SCID interview, clinical mental status examination, discussions with previous psychiatrist or treatment provider if formerly in treatment.

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

Clinical Interview

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

Clinical Interview

6. Current participation in another intensive substance abuse treatment program.

Clinical Interview

7. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week). Clinical Interview; Urine toxicology.

8. Only available significant other is an active substance abuser, has an active psychiatric or medical illness which would interfere with participation (e.g., chronic psychosis, depression with suicide risk), or has a history of significant physical violence with the participant.

Clinical Interview

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.

Clinical Interview