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

NCT00142844 | Completed Phase 2

• 3 other identifiers: NIDA-12756-1P50DA012756-01DPMC
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders

Keywords

cocaine

Outcome Measures

Primary Outcomes (1)

• Amount of alcohol and drug use.

  3 months

Study Arms (4)

Naltrexone

EXPERIMENTAL

Naltrexone

Drug: Naltrexone

Disulfiram

EXPERIMENTAL

Disulfiram

Drug: Disulfiram

Naltrexone and Disulfiram

EXPERIMENTAL

Naltrexone and Disulfiram

Drug: Naltrexone; Drug: Disulfiram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Naltrexone DRUG

Naltrexone; Naltrexone and Disulfiram

Disulfiram DRUG

Disulfiram; Naltrexone and Disulfiram

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related 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. doi: 10.1016/j.addbeh.2007.11.011. Epub 2007 Nov 17.

  PMID: 18079068 RESULT

Related Links

• University of Pennsylvania Center for Studies of Addiction

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders

Interventions

Naltrexone; Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Helen M Pettinati, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 1999
• Primary Completion: March 1, 2005
• Study Completion: January 1, 2008
• Last Updated: January 12, 2017

Record last verified: 2016-10

Locations

US (1)