The goal of this proposal is to develop a behavioral therapy to be used in conjunction with naltrexone maintenance for the treatment of heroin addiction. Agonist maintenance, primarily with methadone, has been effective for many patients but has numerous limitations. Antagonist maintenance with naltrexone is an alternative, which has not, to date, lived up to its potential. An ideal pharmacotherapy in many respects, it blocks the intoxicating and reinforcing effects of heroin and other opiates, but itself has no opiate-like addictive effects. The clinical usefulness of naltrexone has been limited by at least four factors: l) Difficulty transitioning patients from opiates to naltrexone; 2) Poor compliance; 3) Possible dysphoric effects; and 4) The psycho-therapeutic context. Proposed is a Stage I developmental program (NIDA Behavioral Therapies Development Program PA-94-078), which will design and pilot test a therapeutic approach to address these limitations. Patients will be engaged in treatment together with one or more significant others who will agree to attend sessions and monitor naltrexone compliance. Patients will then be hospitalized for rapid transition from opiates to naltrexone, and discharged to outpatient naltrexone maintenance. Therapy sessions, twice-weekly thereafter, will draw elements from Network Therapy and the Community Reinforcement Approach. Compliance with naltrexone, and abstinence will be reinforced with tokens exchangeable for goods and services. Baseline and ongoing psychiatric assessment will monitor patients for development of dysphoria related either to naltrexone or underlying psychopathology.
Specific aims over the three year proposal are:
Specific Aim #1 : To develop a preliminary treatment manual for the combination of behavior therapy and naltrexone through completion of 20 patients through treatment in an uncontrolled pilot trial.
Specific Aim #2 : To explore the effectiveness and patient acceptability of the combination of behavior therapy and naltrexone through a randomized pilot trial with an attentional control. Based on the outcome of this trial, the therapy and manual will be refined and readied for larger-scale trials.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA010746-03
Application #
2898095
Study Section
Special Emphasis Panel (ZDA1-RXL-E (14))
Project Start
1997-09-30
Project End
2000-07-31
Budget Start
1999-08-01
Budget End
2000-07-31
Support Year
3
Fiscal Year
1999
Total Cost
Indirect Cost
Name
New York State Psychiatric Institute
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
Sullivan, Maria A; Bisaga, Adam; Glass, Andrew et al. (2015) Opioid use and dropout in patients receiving oral naltrexone with or without single administration of injection naltrexone. Drug Alcohol Depend 147:122-9
Mogali, Shanthi; Khan, Nabil A; Drill, Esther S et al. (2015) Baseline characteristics of patients predicting suitability for rapid naltrexone induction. Am J Addict 24:258-64
Sullivan, Maria A; Bisaga, Adam; Mariani, John J et al. (2013) Naltrexone treatment for opioid dependence: does its effectiveness depend on testing the blockade? Drug Alcohol Depend 133:80-5
Mariani, John J; Cheng, Wendy Y; Bisaga, Adam et al. (2011) Comparison of clinical trial recruitment populations: treatment-seeking characteristics of opioid-, cocaine-, and cannabis-using participants. J Subst Abuse Treat 40:426-30
Brooks, Adam C; Comer, Sandra D; Sullivan, Maria A et al. (2010) Long-acting injectable versus oral naltrexone maintenance therapy with psychosocial intervention for heroin dependence: a quasi-experiment. J Clin Psychiatry 71:1371-8
Carpenter, Kenneth M; Jiang, Huiping; Sullivan, Maria A et al. (2009) Betting on change: modeling transitional probabilities to guide therapy development for opioid dependence. Psychol Addict Behav 23:47-55
Raby, Wilfrid Noel; Carpenter, Kenneth M; Rothenberg, Jami et al. (2009) Intermittent marijuana use is associated with improved retention in naltrexone treatment for opiate-dependence. Am J Addict 18:301-8
Sullivan, Maria A; Garawi, Fatima; Bisaga, Adam et al. (2007) Management of relapse in naltrexone maintenance for heroin dependence. Drug Alcohol Depend 91:289-92
Sullivan, Maria A; Rothenberg, Jami L; Vosburg, Suzanne K et al. (2006) Predictors of retention in naltrexone maintenance for opioid dependence: analysis of a stage I trial. Am J Addict 15:150-9
Nunes, Edward V; Rothenberg, Jami L; Sullivan, Maria A et al. (2006) Behavioral therapy to augment oral naltrexone for opioid dependence: a ceiling on effectiveness? Am J Drug Alcohol Abuse 32:503-17

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