Effect of Donepezil on Smoking
Condition: Smoking
Intervention: Donepezil; Placebo
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, human laboratory study using a between-subject design between smokers who are randomized to either donepezil HCL (Aricept®) (n=15) or placebo (n=15) for 4 weeks. Treatment randomization will be done to match both groups for age and sex.
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Non-treatment seeking smokers, reporting consumption of at least; 10 cigarettes per day for at least the past 6 months

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.
    

Eligibility 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.