Modafinil for Smoked Cocaine Self-Administration

Completed · Phase 2

Conditions studied: Cocaine Dependence

In brief

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).

Key facts

Study ID

NCT01778010

Run by

New York State Psychiatric Institute

People needed

8

Starts

2009-03-01

Expected to finish

2013-06-01

Last updated by the study team

2018-01-09

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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 -

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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