NCT00115037

Managing Alcoholism in People Who Do Not Respond to Naltrexone

Non-Response to Naltrexone (NTX): Next Steps in Managing Alcoholism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Naltrexone	100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
DRUG	placebo	placebo comparer for 16 weeks in phase 2.
BEHAVIORAL	Medication Management (MM)	Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
BEHAVIORAL	Combined Behavioral Intervention (CBI)	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.
BEHAVIORAL	Telephone Counseling	Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2005-06-21
• Last updated: 2019-09-18
• Results posted: 2019-09-18

Locations

1 site across 1 country: United States