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Completed

NCT Number: NCT00218062

Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Science Center

Houston, Texas, 77030, United States

About this study

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.

This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (SCID) criteria for cocaine abuse or dependence
  • In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.

Exclusion criteria

  • Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
  • Current cardiovascular disease, as determined by an electrocardiogram
  • On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
  • Previously received treatment with d-amphetamine, modafinil, or aripiprazole
  • Currently receiving prescribed medication

Treatment and study plan

D-Amphetamine 30mg

Drug

D-Amphetamine 60mg

Drug

Modafinil 200mg

Drug

Modafinil 400mg

Drug

Therapy

Behavioral

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Placebo

Drug

Primary outcomes

  1. Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment

    Time frame: 16 weeks

  2. Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment

    Time frame: 16 weeks

  3. Retention as Indicated by the Number of Participants Who Remained in the Study

    Time frame: 16 weeks

Secondary outcomes

  1. Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report

    Time frame: 16 weeks

  2. Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2005
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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