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

Phase 2

Completed

• Conditions: Cocaine-Related Disorders; Alcohol-Related Disorders; Alcoholism
• Interventions: Drug: Placebo; Drug: Naltrexone; Drug: Disulfiram

• Registration Number: NCT00142844
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2005-03
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Study Completion: 2008-01
• Status Verified: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Naltrexone	Naltrexone	Naltrexone
Naltrexone and Disulfiram	Disulfiram	Naltrexone and Disulfiram
Disulfiram	Disulfiram	Disulfiram
Naltrexone and Disulfiram	Naltrexone	Naltrexone and Disulfiram

Primary Outcome Measures

Name	Time	Method
Amount of alcohol and drug use.	3 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States