Effect of Donepexil on Smoking
This study has been completed.
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
| 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:
|
| 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:
|
| 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:
|
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:
- 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.
Contacts and Locations
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:
|
Smoking Habits Cholinesterase Inhibitors Donepezil 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 May 16, 2013