Official Title: “Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2005

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.

Intervention(s) in this Clinical Trial

• Drug: Naltrexone
• Drug: Disulfiram
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Naltrexone
  • Naltrexone
• Experimental: Disulfiram
  • Disulfiram
• Experimental: Naltrexone and Disulfiram
  • Naltrexone and Disulfiram
• Placebo Comparator: Placebo
  • Placebo

Primary Measures

• Amount of alcohol and drug use.
  • Time Frame: 3 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Helen M Pettinati, Ph.D. Principal Investigator University of Pennsylvania  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142844

Study ID Number: NIDA-12756-1

ClinicalTrials.gov Identifier: NCT00142844

Health Authority: United States: Food and Drug Administration

University of Pennsylvania Center for Studies of Addiction