Modafinil, Sleep, and Cognition in Cocaine Dependence

Completed · Not applicable · Has a placebo group

Conditions studied: Cocaine Dependence, Substance-induced Sleep Disorder, Substance-induced Cognitive Disorder

In brief

Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.

Key facts

Study ID

NCT00582491

Run by

Yale University

People needed

44

Starts

2006-08-01

Expected to finish

2009-02-01

Last updated by the study team

2012-09-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female individuals, ages 18-65, meeting current DSM-IV criteria for cocaine dependence. Documented positive urine toxicology screen for cocaine at intake and regular 3 times more weekly use of cocaine.
• Subject has voluntarily given informed consent and signed the informed consent document(s).
• Able to read English and complete study evaluations.

You may not qualify if…

• Use of prescription medication in the past 6 months indicating a medical or psychiatric condition that in the opinion of the PI would interfere with study participation (e.g. hypertension, severe renal or hepatic disease, HIV, primary psychotic disorder, primary mood disorder, primary sleep disorder).
• Meeting DSM-IV criteria for dependence on any substance other than cocaine and nicotine.
• Significant underlying medical or psychiatric conditions or hypersensitivity to modafinil that in the opinion of the PI would interfere with study participation.
• Abstinence from cocaine for more than one week prior to inpatient admission.
• Positive urine or serum pregnancy test.
• Women who are pregnant or lactating, or not using a reliable method of birth control.
• (For subjects completing the fMRI portion of the study) Presence of or history indicative of ferromagnetic metal in their bodies.

Where it is running

• Connecticut Mental Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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