Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
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|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|
|Actual Primary Completion Date :||July 2002|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|