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Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

NCT00142818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2020-07-16

Study results available
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Summary

Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. A combination of these two medications may be beneficial in reducing drug and alcohol use in individuals undergoing substance abuse treatment. The purpose of this study is to evaluate the effectiveness of modafinil and naltrexone, alone and in combination, at reducing drug and alcohol use in individuals addicted to cocaine and alcohol.

Conditions

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

Interventions

DRUG

Naltrexone

150 mg daily for males; 100 mg daily for females

DRUG

Modafinil

400 mg daily

DRUG

Placebo

400 mg and/or 100-150 mg placebo pills

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Kyle Kampman

    lead OTHER

Principal Investigators

  • Kyle M. Kampman, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00142818 on ClinicalTrials.gov