Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond poorly to existing treatments and have received little research attention in the past. The purpose of this study is to determine whether the combination of naltrexone and disulfiram is useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and alcohol dependence.

Condition	Intervention	Phase
Alcohol-Related Disorders Alcoholism Cocaine-Related Disorders	Drug: Naltrexone	Phase II

Further Study Details: 

Primary Outcomes: Amount of drug use; measured at Months 6 and 9
Expected Total Enrollment:  208

Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond poorly to existing treatments and have received little research attention in the past. Naltrexone and disulfiram are medications currently approved for treating alcohol dependence. These two medications have differenct mechanisms of action in the body. In combination they might be effective in treating individuals dually diagnosed with cocaine and alcohol dependence. The purpose of this study is to determine whether the combination of naltrexone and disulfiram is useful in decreasing alcohol cravings in individuals who are dependent on both cocaine and alcohol.

Participants in this 5-year, double-blind study will be randomly assigned to receive disulfiram, naltrexone, both, or placebo. Treatment will occur for a 3-month period, after which alcohol, cocaine use, and other biopsychosocial measures will be assessed at Months 6 and 9.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Meets DSM-IV criteria for both alcohol and cocaine dependence, as determined by the Structured Clinical Interview(SCID-IV)
• Successful completion of alcohol detoxification (i.e., 3 consecutive days of abstinence from alcohol)
• Use of at least $100 worth of cocaine in the 30 days prior to enrollment
• Alcoholic consumption of a minimum of 12 standard drinks per week (on average) in the 30 days prior to enrollment
• Alcoholic consumption of 4 or more drinks per day for at least 4 out of the 30 days prior to enrollment, as determined by the Timeline Followback
• Able to commute to the treatment research center
• Speaks, understands, and writes English

Exclusion Criteria:

• Abstinence from alcohol or cocaine for more than 30 days prior to enrollment
• Current DSM-IV diagnosis of any psychoactive substance dependence other than alcohol, cocaine, or nicotine dependence as determined by the SCID
• Opiate use in the 30 days prior to enrollment, as assessed by a self-report and intake urine drug screen test
• History of unstable or serious medical illness, including the need for opioid analgesics
• Concomitant treatment with phenytoin or similarly classed drugs, lithium, serotonin selective reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, or narcotics
• Use of any investigational medication within the 30 days prior to enrollment
• Severe physical or medical illness such as AIDS, active hepatitis, or significant hepatocellular injury as evidenced by elevated bilirubin levels
• Severe psychiatric symptoms (e.g., psychosis, suicidal or homicidal ideation, or mania)
• Females who are pregnant or do not agree to use adequate methods of contraception for the duration of the study

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104 6178,  United States

Study chairs or principal investigators

Helen M Pettinati, Ph.D.,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  NIDA-12756-1; P50-12756-1
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142844
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13