Status:
COMPLETED
Effect of Donepezil on Smoking
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Smoking
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept) for side effects and effects on smoking behavior and performance on neurocognitive tasks in a population of de...
Detailed Description
Nicotine dependence is a major public health problem and currently available treatments are ineffective for the majority of smokers. Thus, there is a need to develop and test novel medications to assi...
Eligibility Criteria
Inclusion
- 30 smokers ages 18-50 who have smoked at least 10 cigarettes per day for the past 6 months, will be eligible to participate. They must be able to provide informed consent.
Exclusion
- Smoking Behavior:
- Current enrollment or plans to enroll in a smoking cessation program, or use other smoking cessation medications in the next 2 months.
- Provide a CO reading less than 10 ppm at medical screening.
- Participants who roll their own cigarettes.
- Regular use of chewing tobacco or snus.
- Alcohol/Drugs 1) History of substance abuse and/or currently receiving treatment for substance abuse (e.g. alcohol, opioids, cocaine, marijuana, or stimulants). 2) Current alcohol consumption that exceeds 25 standard drinks/week. 3) Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at medical screen, baseline, or testing sessions.
- Medical:
- Women who are pregnant, planning a pregnancy, or lactating; all female subjects shall undergo a urine pregnancy test prior to enrollment and must agree in writing to use an approved method of contraception.
- Lifetime history or current diagnosis of psychosis, bipolar disorder, anxiety disorder, or schizophrenia, as identified by the MINI. Individuals with a past history of depression are eligible as long as their major depression episode was more than 6 months ago.
- Serious or unstable disease within the past 6 months i.e. heart disease, liver/kidney failure)
- Other medical conditions such as peptic ulcer disease; beign prostatic hypertrophy or bladder outflow problems; asthma or chronic obstructive pulmonary disease.
- BP reading of 170/100 at medical screening session.
- Medication:
- 1\) Current use, recent discontinuation within last 14 days or planned use of the following medications:
- Any form of smoking cessation medication, i.e. Zyban, Wellbutrin, Wellbutrin SR, Chantix, nicotine replacement therapy
- Psychotropic medications (anti-psychotics, anti-depressants, anti-anxiety or anti-panic medications, mood stabilizers and stimulants)
- Current treatment with other acetylcholinesterase inhibitors (ACIs) like donepezil HCL (Aricept), tacrine, rivgastigmine and galantamine
- Anti-seizure meds, and other meds that affect the cholinergic system such as mecamylamine, atropine, succinylcholine, ketocaonazole, quinidine, bethanechol, iprapropium, bromide, dicyclomine, benztropine, carisprodol, zantac, and procardia.
- 2\) Patients shallbe instructed to refrain from using any study prohibited drugs (note participants are allowed to take prescription medicines not in the exclusion list)throughout their participation in the study.
- Other
- Inability to complete the baseline study procedures within thee hours and/or correctly, as determined by the PI.
- Non-English speakers.
Key Trial Info
Start Date :
January 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01250977
Start Date
January 11 2011
End Date
December 6 2011
Last Update
July 11 2019
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104