Official Title: “Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2005

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 different 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.

Intervention(s) in this Clinical Trial

• Drug: Naltrexone

Primary Measures

• Amount of drug use; measured at Months 6 and 9

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142844

Study ID Number: NIDA-12756-1

ClinicalTrials.gov Identifier: NCT00142844

Health Authority: United States: Food and Drug Administration

University of Pennsylvania Center for Studies of Addiction