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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142844
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 1999
Actual Primary Completion Date : March 2005
Actual Study Completion Date : January 2008

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Amount of alcohol and drug use. [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142844


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Helen M Pettinati, Ph.D. University of Pennsylvania
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Helen Pettinati, Ph.D., University of Pennsylvania Treatment Research Cener
ClinicalTrials.gov Identifier: NCT00142844    
Obsolete Identifiers: NCT00136162
Other Study ID Numbers: NIDA-12756-1
P50DA012756-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine
Additional relevant MeSH terms:
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Disease
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
 Disulfiram
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action