Status:
COMPLETED
Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opiate Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 abst...
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-acti...
Eligibility Criteria
Inclusion
- Adult, aged 18-60. Clinical Interview.
- 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.
- Able to give informed consent. Clinical interview and mental status exam
- 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
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Clinical Interview, physical examination, serum pregnancy test
- 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
- 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.
- History of allergic reaction to buprenorphine, naloxone, naltrexone, clonidine, or clonazepam.
- Clinical Interview
- Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Clinical Interview
- Current participation in another intensive substance abuse treatment program.
- Clinical Interview
- Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (\>30 mg per week). Clinical Interview; Urine toxicology.
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00332228
Start Date
June 1 2002
End Date
December 1 2007
Last Update
October 26 2012
Active Locations (2)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032
2
STARS
New York, New York, United States, 10032