Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
|ClinicalTrials.gov Identifier: NCT00238914|
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : January 13, 2012
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:
- Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy.
- Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.
|Condition or disease||Intervention/treatment||Phase|
|Heroin Dependence||Drug: Naltrexone Behavioral: Behavioral Naltrexone Therapy (BNT) Behavioral: Compliance Enhancement (CE)||Phase 2|
New York State Psychiatric Institute has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Opiate Dependence: Combined Naltrexone/Behavior Therapy|
|Study Start Date :||August 1999|
|Primary Completion Date :||July 2002|
|Study Completion Date :||July 2002|
Active Comparator: CE plus oral naltrexone
Compliance enhancement plus oral naltrexone
50mg of oral naltrexone dailyBehavioral: Compliance Enhancement (CE)
a controlled therapy intended to simulate outpatient psychiatric care.
Active Comparator: BNT plus oral naltrexone
Behavioral naltrexone therapy plus oral naltrexone
50mg of oral naltrexone dailyBehavioral: Behavioral Naltrexone Therapy (BNT)
a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
- Relapse to heroin addiction [ Time Frame: Up to 24 weeks or length of study participation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238914
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Edward Nunes, M.D.||New York State Psychiatric Institute|