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Completed

NCT Number: NCT01778010

Modafinil for Smoked Cocaine Self-Administration

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

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Key information

Conditions

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

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Smokes cocaine
  • Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
  • Age 21-50.
  • Able to give informed consent, and comply with study procedures.
  • Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion criteria

  • Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
  • Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
  • Request for drug treatment
  • Judged to be noncompliant with study protocol.
  • Current use of any psychotropic medication.
  • Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
  • History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
  • Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
  • Current parole or probation Self-report during interview -

Treatment and study plan

Modafinil 0 mg

Drug

Modafinil (0 mg/day)

Modafinil 200 mg

Drug

Modafinil (200 mg/day)

Modafinil 400 mg

Drug

Modafinil (400 mg/day)

Cocaine 0 mg

Drug

Cocaine (0 mg/day)

Cocaine 12 mg

Drug

Cocaine (12 mg/day)

Cocaine 25 mg

Drug

Cocaine (25 mg/day)

Cocaine 50 mg

Drug

Cocaine (50 mg/day)

Primary outcomes

  1. Cocaine Self-administration

    Time frame: 48 days

    The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

Secondary outcomes

  1. Drug Quality Cluster

    Time frame: 48 days

    Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:

    • "the choice was of high quality"
    • "the choice was potent"
    • "I liked the choice" Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome.

  2. Heart Rate

    Time frame: 48 days

    Values for heart rate as a function of cocaine dose and modafinil maintenance condition.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Modafinil in a Human Laboratory Model of Cocaine Relapse

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2013
Registry last updated
Jan 9, 2018

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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