Clinical trial NCT00115037
Conditions: Alcoholism
Keywords: Alcoholism alcohol abuse therapy drug resistance naltrexone patient care management human subject
Sponsor: University of Pennsylvania
Start date: 2003-09-01; Completion date: 2008-07-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in motivating patients to greater medication adherence and may address psychosocial factors that may limit the effects of naltrexone.

Detailed description:
Naltrexone has been established as an efficacious medication to treat alcohol dependence but studies thus far have focused mostly on the acute phase of treatment rather than long-term management and have not offered alternative treatment strategies when patients do not respond to an initial course of naltrexone. For these initial non-responders to naltrexone, it is unclear what adjustments to treatment should be made to increase the likelihood of treatment success. We are unaware of previous research focused specifically on naltrexone non-response. Pilot data from ongoing trials at our center, however, suggest that up to a third of patients fail to respond to naltrexone. Moreover, these non-responsive patients go on to have the worst outcomes during the next 6 months of treatment if maintained on the same combination of naltrexone and medication management (MM). We propose to augment medication management with a combination of motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention - CBI) and to test the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. Clinical strategies for second line treatments often favor switching treatments rather than augmentation. However, there may be synergies between naltrexone and CBI that were not apparent with medication management. Specifically, CBI may have advantages in motivating patients to greater medication adherence (a leading cause of naltrexone treatment failure) and CBI may address psychosocial factors that limited or attenuated the effects of naltrexone.

Arms: arm 1: From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder. arm 2: From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 2 or heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder. arm 3: Phase 2: Naltrexone and telephone counseling for responders. arm 4: Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR). arm 5: Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR) arm 6: Phase 2: Naltrexone and TAU for phase 1 responders.
Interventions: intervention 1: Naltrexone intervention 2: placebo intervention 3: Medication Management (MM) intervention 4: Combined Behavioral Intervention (CBI) intervention 5: Telephone Counseling
Intervention descriptions: intervention 1: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. intervention 2: placebo comparer for 16 weeks in phase 2. intervention 3: Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2. intervention 4: 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks. intervention 5: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.

Protocol documents: