Effect of Donepezil on Smoking

• Status: Completed
• Trial end date: 2011-12-06
• Target enrollment: 0
• Participant gender: All

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 dependent smokers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Cholinesterase Inhibitors; Donepezil

Criteria

Inclusion Criteria:

• 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 Criteria:

• Smoking Behavior:

1. Current enrollment or plans to enroll in a smoking cessation program, or use other smoking cessation medications in the next 2 months.

2. Provide a CO reading less than 10 ppm at medical screening.

3. Participants who roll their own cigarettes.

4. 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:

1. 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.

2. 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.

3. Serious or unstable disease within the past 6 months i.e. heart disease, liver/kidney failure)

4. Other medical conditions such as peptic ulcer disease; beign prostatic hypertrophy or bladder outflow problems; asthma or chronic obstructive pulmonary disease.

5. 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

1. Inability to complete the baseline study procedures within thee hours and/or correctly, as determined by the PI.

2. Non-English speakers.