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

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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)

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE September 1999
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Amount of alcohol and drug use. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Amount of drug use; measured at Months 6 and 9
Change History Complete list of historical versions of study NCT00142844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1
Official Title  ICMJE Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence
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.
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 Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol-Related Disorders
  • Alcoholism
  • Cocaine-Related Disorders
Intervention  ICMJE
  • Drug: Naltrexone
  • Drug: Disulfiram
  • Drug: Placebo
Study Arms
  • Experimental: Naltrexone
    Naltrexone
    Intervention: Drug: Naltrexone
  • Experimental: Disulfiram
    Disulfiram
    Intervention: Drug: Disulfiram
  • Experimental: Naltrexone and Disulfiram
    Naltrexone and Disulfiram
    Interventions:
    • Drug: Naltrexone
    • Drug: Disulfiram
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Pettinati HM, Kampman KM, Lynch KG, Xie H, Dackis C, Rabinowitz AR, O'Brien CP. A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence. Addict Behav. 2008 May;33(5):651-67. Epub 2007 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2005)
208
Original Enrollment  ICMJE Same as current
Actual Study Completion Date January 2008
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142844
Other Study ID Numbers  ICMJE NIDA-12756-1
P50DA012756-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Helen Pettinati, Ph.D., University of Pennsylvania Treatment Research Cener
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Helen M Pettinati, Ph.D. University of Pennsylvania
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP