Modafinil, Sleep, and Cognition in Cocaine Dependence
Condition: Cocaine Dependence; Substance-induced Sleep Disorder; Substance-induced Cognitive Disorder
MeSH terms: Sleep Wake Disorders; Cocaine-Related Disorders; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      A relatively new treatment for the excessive daytime sleepiness (EDS) associated with
      inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective
      measures of daytime sleepiness under conditions of sleep restriction, while enhancing
      cognitive performance. At the same time, sleep quality does not appear to be affected
      significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest
      that modafinil reduces the relapse to cocaine use, by unknown mechanisms.

      We propose to employ both subjective and objective measures of nocturnal sleep and daytime
      sleepiness, as well as measures of general cognitive performance and sleep-dependent memory
      consolidation, to explore potential mechanistic relationships between cocaine abstinence,
      EDS, and modafinil's efficacy in preventing cocaine relapse.

      The following specific aims are proposed:

      Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g.,
      reduced total sleep time and sleep efficiency) that progressively characterize periods of
      sustained cocaine abstinence are also associated with objective evidence of excessive daytime
      sleepiness (EDS).

      Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime
      sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.

      Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in
      objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether
      successful abstinence from cocaine is associated with normalization of the same.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Modafinil 400mg orally every day for 16 days; Placebo orally everyday for 16 days
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Modafinil; Sleep; Cognition; Cocaine Dependence