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Modafinil, Sleep, and Cognition in Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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
History of Changes
Results First Received: August 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Conditions: Cocaine Dependence
Substance-induced Sleep Disorder
Substance-induced Cognitive Disorder
Interventions: Drug: Modafinil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
44 participants with self-identified cocaine problems responded to newspaper advertisements and passed initial telephone screening. Of those who passed the telephone screening, 29 were found to be qualified for participation after in-person screening. 21 participants entered the study and were subsequently randomized.

Reporting Groups
  Description
Modafinil 400mg Modafinil 400mg orally everyday for 16 days
Placebo Placebo orally everyday for 16 days

Participant Flow:   Overall Study
    Modafinil 400mg     Placebo  
STARTED     11     10  
COMPLETED     10     10  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Modafinil (400mg) Participants received single oral dose of modafinil (400mg) every morning for 16 days
Placebo Participants received a single oral placebo every morning for 16 days
Total Total of all reporting groups

Baseline Measures
    Modafinil (400mg)     Placebo     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation 		  41.9  ± 3.7     43.9  ± 8.4     42.9  ± 6.4  
Gender  
[units: participants]
 		     
Female     3     1     4  
Male     7     9     16  



  Outcome Measures
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1.  Primary:   Total Sleep Time (Minutes)   [ Time Frame: After 1 Week ]
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2.  Primary:   Total Sleep Time (Minutes)   [ Time Frame: After 2 Weeks ]
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3.  Primary:   Total Sleep Time (Minutes)   [ Time Frame: After 3 Weeks ]
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4.  Primary:   Time Spent in Sleep Stage 3 (Minutes)   [ Time Frame: After 1 Week ]
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5.  Primary:   Time Spent in Sleep Stage 3 (Minutes)   [ Time Frame: After 2 Weeks ]
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6.  Primary:   Time Spent in Sleep Stage 3 (Minutes)   [ Time Frame: After 3 Weeks ]
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7.  Secondary:   Overall Sleep Quality on Visual Analog Scale (Millimeters)   [ Time Frame: After 1 Week ]
  Show Outcome Measure 7

8.  Secondary:   Overall Sleep Quality on Visual Analog Scale (Millimeters)   [ Time Frame: After 2 Weeks ]
  Show Outcome Measure 8

9.  Secondary:   Overall Sleep Quality on Visual Analog Scale (Millimeters)   [ Time Frame: After 3 Weeks ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Peter Morgan, MD, PhD
Organization: Yale University School of Medicine
phone: 203-974-7515
e-mail: Peter.Morgan@yale.edu


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