Use of Donepezil for Treatment of Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467389
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cocaine Abuse and Dependence
Interventions: Drug: Donepezil, 5 mg daily
Other: Oral Placebo

  Participant Flow

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
No text entered.

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

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

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

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.

  More Information

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 ( US Department of Veterans Affairs ) Identifier: NCT00467389     History of Changes
Other Study ID Numbers: NEUA-014-05S
First Submitted: April 27, 2007
First Posted: April 30, 2007
Results First Submitted: December 18, 2013
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014