Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
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.
Behavioral: Behavioral Naltrexone Therapy (BNT)
Behavioral: Compliance Enhancement (CE)
New York State Psychiatric Institute has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Opiate Dependence: Combined Naltrexone/Behavior Therapy|
- Relapse to heroin addiction [ Time Frame: Up to 24 weeks or length of study participation ] [ Designated as safety issue: No ]
|Study Start Date:||August 1999|
|Study Completion Date:||July 2002|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
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
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 to naltrexone precipitates opiate withdrawal unless the patient has been off any opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone doses and begin to experience effects from illicit opiates and become re-addicted, at which point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may produce dysphoria in some patients. The proposed research study will offer opiate dependent patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification at an outside unit, they will be assessed for opiate dependence using the naloxone challenge. Patients will then be either discharged or entered directly into outpatient treatment where they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy" (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the family and social network to reinforce naltrexone compliance and abstinence. In this current investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients are stratified at baseline by presence or absence of lifetime depressive disorder, which the investigators hypothesize will predict dysphoria on naltrexone and non-compliance. Patients are discharged from the hospital, or entered directly, into outpatient treatment at STARS at NYSPI to receive both counseling and Naltrexone, 50 mg per day.
Please refer to this study by its ClinicalTrials.gov identifier: 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|