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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00142844

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

208

Enrollment

Location

Arms

100

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders Alcoholism Cocaine-Related Disorders	Drug: Naltrexone Drug: Disulfiram Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naltrexone Naltrexone	Drug: Naltrexone
Experimental: Disulfiram Disulfiram	Drug: Disulfiram
Experimental: Naltrexone and Disulfiram Naltrexone and Disulfiram	Drug: Naltrexone Drug: Disulfiram
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Amount of alcohol and drug use. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.