Trial Outcomes & Findings for Use of Donepezil for Treatment of Cocaine Dependence (NCT NCT00467389)

NCT ID: NCT00467389

Last Updated: 2014-06-09

Results Overview

Patients evaluated for clinical and laboratory adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Two weeks
• Results posted on: 2014-06-09

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Donepezil for Treatment of Cocaine Dependence

Baseline characteristics by cohort

Measure	All Participants n=12 Participants All recruited subjects
Age, Continuous	46.4 Years STANDARD_DEVIATION 0.8 • n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: Two weeks

Population: All participants included

Patients evaluated for clinical and laboratory adverse events

Outcome measures

Measure	Placebo Treatment Period n=12 Participants Inactive Comparator	Donepezil Treatment Period n=12 Participants Active Treatment
Cocaine Safety in Subjects Receiving Donepezil	0 Participants with an Adverse Event	2 Participants with an Adverse Event

SECONDARY outcome

Timeframe: 3 to 30 minutes

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).

Outcome measures

Measure	Placebo Treatment Period n=12 Participants Inactive Comparator	Donepezil Treatment Period n=12 Participants Active Treatment
Cocaine Subjective Effects	44.1 mm Standard Error 17.8	89.9 mm Standard Error 35.3

SECONDARY outcome

Timeframe: 0 to 8 hours

Area-Under-the-Curve for Plasma Concentration

Outcome measures

Measure	Placebo Treatment Period n=12 Participants Inactive Comparator	Donepezil Treatment Period n=12 Participants Active Treatment
Cocaine Pharmacokinetics	34,503 ng-hr/ml Standard Error 3,599	40,812 ng-hr/ml Standard Error 5,244

Adverse Events

Placebo Treatment Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Donepezil Treatment Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Treatment Period n=12 participants at risk Inactive Comparator.	Donepezil Treatment Period n=12 participants at risk Active Treatment
Gastrointestinal disorders Gastrointestinal distress	0.00% 0/12	8.3% 1/12 • Number of events 1
Gastrointestinal disorders Chest discomfort	0.00% 0/12	8.3% 1/12 • Number of events 1

Additional Information

Kenneth Grasing

Substance Abuse Research Laboratory, Kansas City VA Medical Center

Phone: (816) 922-2756

Email: kenneth.grasing@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place