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Use of Donepezil for Treatment of Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT00467389
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
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
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Treatment First Donepezil Treatment First
Hide Arm/Group Description Participants initially treated with oral placebo, and later treated with oral donepezil Participants initially treated with oral donepezil, and later treated with oral placebo
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All recruited subjects
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
All participating subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
46.4  (0.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Cocaine Safety in Subjects Receiving Donepezil
Hide Description Patients evaluated for clinical and laboratory adverse events
Time Frame Two weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants included
Arm/Group Title Placebo Treatment Period Donepezil Treatment Period
Hide Arm/Group Description:
Inactive Comparator
Active Treatment
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: Participants with an Adverse Event
0 2
2.Secondary Outcome
Title Cocaine Subjective Effects
Hide Description Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).
Time Frame 3 to 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treatment Period Donepezil Treatment Period
Hide Arm/Group Description:
Inactive Comparator
Active Treatment
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: mm
44.1  (17.8) 89.9  (35.3)
3.Secondary Outcome
Title Cocaine Pharmacokinetics
Hide Description Area-Under-the-Curve for Plasma Concentration
Time Frame 0 to 8 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treatment Period Donepezil Treatment Period
Hide Arm/Group Description:
Inactive Comparator
Active Treatment
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: ng-hr/ml
34,503  (3,599) 40,812  (5,244)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Treatment Period Donepezil Treatment Period
Hide Arm/Group Description Inactive Comparator. Active Treatment
All-Cause Mortality
Placebo Treatment Period Donepezil Treatment Period
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treatment Period Donepezil Treatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Treatment Period Donepezil Treatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      2/12 (16.67%)    
Gastrointestinal disorders     
Gastrointestinal distress  1 [1]  0/12 (0.00%)  0 1/12 (8.33%)  1
Chest discomfort  2 [2]  0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Nausea
2
Term from vocabulary, Discomfort
[1]
One patient experienced a single episode of nausea and vomiting on his second day of treatment with donepezil that resolved spontaneously.
[2]
An additional patient reported 5 minutes of mild chest discomfort that he attributed to eating too much during his third day of donepezil treatment, with no electrocardiogram changes observed.
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov 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