Phase 2
Completed N=20
Effect of Donepezil on Smoking
Source: ClinicalTrials.gov NCT01250977 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in True Positives on the 3-Back Level of the Letter-N-Back Neurocognitive Task at Day 28 (i.e., Week 4) — .59; 3.4 True positive responses
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in True Positives on the 3-Back Level of the Letter-N-Back Neurocognitive Task at Day 28 (i.e., Week 4) |
.59; 3.4 | — |
| PRIMARY Change From Baseline in Discriminability on the Penn Continuous Performance Neurocognitive Task at Day 28 (i.e., Week 4) |
-.1; .5 | — |
| SECONDARY Change From Baseline in Smoking Behavior (i.e., Cigarettes Per Day) at Day 28 (i.e., Week 4) |
3.3; 1.9 | — |
| SECONDARY Summary Side Effect Score at Day 28 (i.e., Week 4) |
2.3; 1.1 | — |
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:
- 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:
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01250977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.