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

Alcoholism Clinical Trial

Official title:

Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142844
• Other study ID #: NIDA-12756-1
• Secondary ID: P50DA012756-01DP
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: January 11, 2017
• Start date: September 1999
• Est. completion date: January 2008

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00136162

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: January 2008
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Alcoholism
• Cocaine-Related Disorders
• Disease

Intervention

Drug:
• Naltrexone

• Disulfiram

• Placebo

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of alcohol and drug use.		3 months	No

External Links

•   University of Pennsylvania Center for Studies of Addiction