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

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.

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.