Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Disulfiram; Naltrexone

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

• In the past 30 days, Subject used no less than $100 worth of cocaine and drank a minimum of 12 standard alcohol drinks/week (on average), having at least four days in 30 where at least four or more drinks were ingested, as determined by the Timeline Followback (TLFB) - adapted to collect daily cocaine use;

• Able to commute to the treatment research center

• Speaks, understands, and writes English

• Understands and signs the informed consent.

Exclusion Criteria:

• Abstinence from alcohol or cocaine for more than 30 days before signing consent form

• Current DSM-IV diagnosis of any psychoactive substance dependence other than Alcohol, Cocaine or Nicotine dependence, as determined by the SCID;

• Evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screen;

• History of unstable or serious medical illness, including need for opioid analgesics;

• Concomitant treatment with phenytoin or from same drug class, lithium, serotonin selective reuptake inhibitors, tricyclic antidepressants, MAOI's or narcotics; 6) Use of any investigational medication within the past 30 days;

• 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;

• Female patients who are pregnant, nursing, or not using a reliable method of contraception. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, oral contraceptives.