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 test 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.

Condition	Intervention	Phase
Alcoholism	Drug: Naltrexone	Phase IV

Further Study Details: 

Primary Outcomes: Reduction in alcohol use at 8 months
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 18 years of age or older
• Current DSM-IV diagnosis of alcohol dependence
• Meets the following drinking criteria as measured by the Timeline Followback (TLFB): * drank within 30 days of randomization; * reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk.) in a consecutive 30-day period over the 90-day period prior to starting NTX (i.e., a minimum of 40% days drinking); and * has 2 or more days of heavy drinking (defined as over 4 drinks per day in males and over 3 drinks per day in females) in this same pre-treatment period
• Prior to starting NTX, at least 3 consecutive days of abstinence, as determined by subject report and breathalyzer measures
• Speaks, understands and prints in English.

Exclusion Criteria:

• Has abused or been dependent on opiates in the past 12 months, or evidence of opiate use in month prior to treatment, as assessed by subject report and intake urine drug screen.
• Meets DSM-IV criteria for current dependence on any substance other than alcohol, nicotine, or marijuana.
• Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any psychotic disorder, or organic mental disorder.
• Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4 times normal after the required 4 days of abstinence, or elevated bilirubin (more than 10% above the ULN).
• Has evidence of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
• Has taken any psychotropic medications (or disulfiram) regularly within the last seven days prior to randomization.
• Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the subject is of child-bearing potential.

Please refer to this study by ClinicalTrials.gov identifier  NCT00115037

David W. Oslin, M.D.      215-615-3083    oslin@mail.med.upenn.edu

Pennsylvania
      University of Pennsylvania Treatment Research Center, Chestnut Street, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study chairs or principal investigators

David W. Oslin, M.D.,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  NIAAAOSL014851
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 20, 2005
ClinicalTrials.gov Identifier:  NCT00115037
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05