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

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University of Pennsylvania

Status and phase

Completed
Phase 2

Conditions

Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders

Treatments

Drug: Disulfiram
Drug: Placebo
Drug: Naltrexone

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00142844
P50DA012756-01 (U.S. NIH Grant/Contract)
NIDA-12756-1
DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

208 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

208 participants in 4 patient groups, including a placebo group

Naltrexone
Experimental group
Description:
Naltrexone
Treatment:
Drug: Naltrexone
Disulfiram
Experimental group
Description:
Disulfiram
Treatment:
Drug: Disulfiram
Naltrexone and Disulfiram
Experimental group
Description:
Naltrexone and Disulfiram
Treatment:
Drug: Disulfiram
Drug: Naltrexone
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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