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Use of Donepezil for Treatment of Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00467389
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;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, 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
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
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  
NOT COMPLETED     0     0  



  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
  Description
All Participants All recruited subjects

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  12  
Age  
[units: Years]
Mean ± Standard Deviation
  46.4  ± 0.8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
  Show All Outcome Measures

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
e-mail: kenneth.grasing@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov 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
Health Authority: United States: Federal Government
United States: Food and Drug Administration