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Modafinil, Sleep Architecture and Cocaine Relapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01137396
First received: June 3, 2010
Last updated: March 24, 2016
Last verified: March 2016
Results First Received: March 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Modafinil
Behavioral: Cognitive Behavioral Therapy

  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
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Reporting Groups
  Description
Modafinil

Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks

Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence

Placebo

Placebo: Placebo medication Qdaily for ~8weeks

Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence


Participant Flow:   Overall Study
    Modafinil   Placebo
STARTED   30   27 
COMPLETED   22   25 
NOT COMPLETED   8   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Modafinil

Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks

Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence

Placebo

Placebo: Placebo medication Qdaily for ~8weeks

Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence

Total Total of all reporting groups

Baseline Measures
   Modafinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   27   57 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (7)   44  (7)   43  (7) 
Gender 
[Units: Participants]
     
Female   7   6   13 
Male   23   21   44 


  Outcome Measures
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1.  Primary:   %Cocaine Free Urines   [ Time Frame: 3x/week ]

2.  Secondary:   Change in N3 (Slow-wave) Sleep Time   [ Time Frame: change from week 1 to week 2 of inpatient treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Morgan
Organization: Yale University
phone: 203-974-7560
e-mail: peter.morgan@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01137396     History of Changes
Other Study ID Numbers: 0911005989
DA011744-08
Study First Received: June 3, 2010
Results First Received: March 24, 2016
Last Updated: March 24, 2016
Health Authority: United States: Institutional Review Board