Clinical Trial: Managing Alcoholism in People Who Do Not Respond to Naltrexone

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Pennsylvania

Current Primary Outcome: Reduction in alcohol use for subjects treated with a combination of CBI and NTX compared to CBI and placebo in those subjects who failed to respond to MM and NTX. [ Time Frame: 16 weeks ]

Original Primary Outcome: Reduction in alcohol use at 8 months

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: June 20, 2005
Date Started: September 2003
Date Completion:
Last Updated: August 4, 2011
Last Verified: August 2011