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Use of Donepezil for Treatment of Cocaine Dependence

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: April 27, 2007
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: December 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cocaine Abuse and Dependence
Interventions: Drug: Donepezil, 5 mg daily
Other: Oral 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
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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
Placebo Treatment First Participants initially treated with oral placebo, and later treated with oral donepezil
Donepezil Treatment First Participants initially treated with oral donepezil, and later treated with oral placebo

Participant Flow:   Overall Study
    Placebo Treatment First   Donepezil Treatment First
STARTED   6   6 
COMPLETED   6   6 

  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.
All participating subjects

Reporting Groups
All Participants All recruited subjects

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 46.4  (0.8) 
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   0 
[Units: Participants]
Female   0 
Male   12 
Region of Enrollment 
[Units: Participants]
United States   12 

  Outcome Measures
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1.  Primary:   Cocaine Safety in Subjects Receiving Donepezil   [ Time Frame: Two weeks ]

2.  Secondary:   Cocaine Subjective Effects   [ Time Frame: 3 to 30 minutes ]

3.  Secondary:   Cocaine Pharmacokinetics   [ Time Frame: 0 to 8 hours ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Kenneth Grasing
Organization: Substance Abuse Research Laboratory, Kansas City VA Medical Center
phone: (816) 922-2756

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT00467389     History of Changes
Other Study ID Numbers: NEUA-014-05S
Study First Received: April 27, 2007
Results First Received: December 18, 2013
Last Updated: May 21, 2014