Effect of Donepexil on Smoking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01250977
First received: October 20, 2010
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept), for adherence, side effects and effects on smoking behavior in a population of dependent smokers.


Condition Intervention Phase
Smoking
Drug: Donepezil
Phase 2

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Effect of Acetylcholinesterase Inhibitors on Smoking Behavior

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Smoking Topography [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Smoking Rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Will assess cigarettes smoked in during the medical screening, baseline session, and throughout the medication period. A standard timeline follow-back method will be used to assess self-reported smoking rate. Participants will also be asked to return their used cigarette butts during each in-person session to verify their smoking rate.

  • Pill Counts/Adherence [ Designated as safety issue: Yes ]
    Medication adherence will be assessed by pill count. Self-reorted adherence by pill count will be assessed prior to each study visit.

  • Withdrawal Symptoms [ Designated as safety issue: Yes ]
    Will assess nicotine withdrawal including dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, decreased heart rate, difficulty concentrating, restlessness, and increased appetite/weight gain.

  • Smoking Urges [ Designated as safety issue: Yes ]
    The 10-item brief QSU questionnaire will be used to assess smoking urges at medical screening, baseline session and testing days. The QSU contains 2 subscales (anticipation of reward, relief from negative affect).

  • First Cigarette Smoking Questionnaire [ Designated as safety issue: No ]
    This 13-item questionnaire will assess if there is any change in the rewarding value of the first cigarette of the day as compared to the remaining cigarette smoked by the participants throughout the day. This will be asked at the baseline session and 4 testing days.

  • Neurocognitive Measures [ Designated as safety issue: No ]
    To measure attention and working memory.

  • Side Effects [ Designated as safety issue: Yes ]
    A checklist of side effects based on the Aricept product insert will be administered to participants at the observation and testing days. Participants will receive written instructions to call the study physician should they experience any severe side effects or adverse events between study visits.


Estimated Enrollment: 30
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Adherence Drug: Donepezil
5 mg donepezil HCL (Aricept) Participants will be instructed to take one 5 mg pill every night before going to bed with a glass of water for 28 days. In case participants experience difficulty they will be allowed to take the study medication in the morning.
Other Names:
  • Marketed for treatment of Alzheimer's disease. Though Donepezil has been administered
  • to non-Alzheimer's healthy volunteers in multiple studies (18-23), this will be the 1st study that will
  • administer donepezil HCL (Aricept) to a population of health smokers.
Placebo Comparator: Side Effects Drug: Donepezil
5 mg donepezil HCL (Aricept) Participants will be instructed to take one 5 mg pill every night before going to bed with a glass of water for 28 days. In case participants experience difficulty they will be allowed to take the study medication in the morning.
Other Names:
  • Marketed for treatment of Alzheimer's disease. Though Donepezil has been administered
  • to non-Alzheimer's healthy volunteers in multiple studies (18-23), this will be the 1st study that will
  • administer donepezil HCL (Aricept) to a population of health smokers.
Placebo Comparator: Smoking behavior Drug: Donepezil
5 mg donepezil HCL (Aricept) Participants will be instructed to take one 5 mg pill every night before going to bed with a glass of water for 28 days. In case participants experience difficulty they will be allowed to take the study medication in the morning.
Other Names:
  • Marketed for treatment of Alzheimer's disease. Though Donepezil has been administered
  • to non-Alzheimer's healthy volunteers in multiple studies (18-23), this will be the 1st study that will
  • administer donepezil HCL (Aricept) to a population of health smokers.
Placebo Comparator: Cognitive Assessments Drug: Donepezil
5 mg donepezil HCL (Aricept) Participants will be instructed to take one 5 mg pill every night before going to bed with a glass of water for 28 days. In case participants experience difficulty they will be allowed to take the study medication in the morning.
Other Names:
  • Marketed for treatment of Alzheimer's disease. Though Donepezil has been administered
  • to non-Alzheimer's healthy volunteers in multiple studies (18-23), this will be the 1st study that will
  • administer donepezil HCL (Aricept) to a population of health smokers.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250977

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Andrew Strasser, MBBS, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01250977     History of Changes
Other Study ID Numbers: UPCC 12910
Study First Received: October 20, 2010
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Non-treatment seeking smokers, reporting consumption of at least
10 cigarettes per day for at least the past 6 months

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014