Status:
COMPLETED
Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Heroin Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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...
Detailed Description
Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence, but has not been successful clinically because of at least three problems: 1) The transition from opiate t...
Eligibility Criteria
Inclusion
- Inclusion:
- Adult, aged 18-60.
- 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.
- Able to give informed consent.
- At least one significant other is willing to be interviewed for possible participation in the treatment.
- Exclusion:
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- 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.
- 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.
- History of allergic reaction to naloxone, naltrexone, buprenorphine, clonidine, or clonazepam.
- Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Current participation in another intensive treatment program or currently prescribed psychotropic medications in the last 30 days.
- Current participation in a Methadone Maintenance program and/or regular and/or Dependent use of street methadone.
- Opiate-dependent individuals who are seeking methadone maintenance treatment.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00238914
Start Date
August 1 1999
End Date
July 1 2002
Last Update
January 13 2012
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032