Modafinil, Sleep, and Cognition in Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00582491
First received: December 21, 2007
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Cocaine Dependence
Substance-induced Sleep Disorder
Substance-induced Cognitive Disorder
Drug: Modafinil
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Modafinil, Sleep, and Cognition in Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Total Sleep Time (Minutes) [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.


  • Total Sleep Time (Minutes) [ Time Frame: After 2 Weeks ] [ Designated as safety issue: No ]

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.


  • Total Sleep Time (Minutes) [ Time Frame: After 3 Weeks ] [ Designated as safety issue: No ]

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.


  • Time Spent in Sleep Stage 3 (Minutes) [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

  • Time Spent in Sleep Stage 3 (Minutes) [ Time Frame: After 2 Weeks ] [ Designated as safety issue: No ]
    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

  • Time Spent in Sleep Stage 3 (Minutes) [ Time Frame: After 3 Weeks ] [ Designated as safety issue: No ]
    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.


Secondary Outcome Measures:
  • Overall Sleep Quality on Visual Analog Scale (Millimeters) [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]

    Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

    Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.


  • Overall Sleep Quality on Visual Analog Scale (Millimeters) [ Time Frame: After 2 Weeks ] [ Designated as safety issue: No ]

    Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

    Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.


  • Overall Sleep Quality on Visual Analog Scale (Millimeters) [ Time Frame: After 3 Weeks ] [ Designated as safety issue: No ]

    Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

    Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.



Enrollment: 44
Study Start Date: August 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Modafinil 400mg orally everyday for 16 days
Drug: Modafinil
Modafinil 400mg orally every day for 16 days
Other Name: Provigil
Placebo Comparator: II
Placebo orally everyday for 16 days
Drug: Placebo
Placebo orally everyday for 16 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582491

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Peter T Morgan, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00582491     History of Changes
Other Study ID Numbers: 0607001659, R01DA011744, R01DA11744
Study First Received: December 21, 2007
Results First Received: August 6, 2012
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Modafinil
Sleep
Cognition
Cocaine Dependence

Additional relevant MeSH terms:
Cognition Disorders
Sleep Disorders
Parasomnias
Cocaine-Related Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Cocaine
Modafinil
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants
Neuroprotective Agents

ClinicalTrials.gov processed this record on July 10, 2014