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The Effect of Acetylcholinesterase Inhibitors on Smoking Behavior

Phase 2
18 Years
50 Years
Not Enrolling

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Trial Information

The Effect of Acetylcholinesterase Inhibitors on Smoking Behavior

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 assist smokers to quit smoking. Recent evidence from two genetic studies by
our group implicates the endogenous cholinergic system in smoking cessation and nicotine
dependence, Pre-clinical investigations have also demonstrated an important role for the
endogenous cholinergic system in nicotine addiction. The proposed proof of concept pilot
study is a randomized Phase 2a trial designed to study the effects of Donepezil
hydrochloride (HCL) (Aricept), compared to placebo, on smoking behavior in 24 smokers. Key
outcomes include, adherence, side effects, smoking rate, and smoking topography.

Inclusion Criteria:

- 20 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

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

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.

Type of Study:


Study Design:

Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Smoking Topography

Outcome Description:

At each visit, the participant will smoke a cigarette using a portable, hand held smoking topography device. The topography machine which will measure number of puffs, puff volume, puff velocity, interpuff interval, and peak velocity for each puff. The primary outcome measures will be the number of puffs and total puff volume.

Safety Issue:


Principal Investigator

Andrew Strasser, MBBS, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 12910



Start Date:

October 2010

Completion Date:

July 2012

Related Keywords:

  • Smoking
  • Non-treatment seeking smokers, reporting consumption of at least
  • 10 cigarettes per day for at least the past 6 months
  • Smoking



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283