Effect of Donepezil on Smoking

NCT01250977 | Completed Phase 2 Results DMC

• 1 other identifier: UPCC 12910
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  Neurocognitive task performance was assessed during baseline and each testing day (Day 7, 14, 21, and 28) using computerized tasks. Working memory was assessed with the Letter-N-back task.

  Baseline and Day 28

• Change From Baseline in Discriminability on the Penn Continuous Performance Neurocognitive Task at Day 28 (i.e., Week 4)

  Sustained attention was assessed with the Penn Continuous Performance Task (P-CPT). The primary outcome measure was the change from Baseline in discriminability (score) on the P-CPT at Day 28. The discriminability score is the mathematical difference between the total correct (i.e., true positives and correct non-responses) and incorrect (i.e., errors of commission and omission) responses to a series of stimuli presented during the P-CPT. The unit of measure is number of correct responses less the number of incorrect responses. A higher discriminability score at a single time point indicates a better performance on the P-CPT. A positive change in discriminability score between Baseline and Day 28 indicates improved performance over time. In its purest mathematical sense, the discriminability measure is a difference of difference scores and therefore is without scale limits, that is, there are no minimum or maximum values one could theoretically obtain.

  Baseline and Day 28

Secondary Outcomes (2)

• Change From Baseline in Smoking Behavior (i.e., Cigarettes Per Day) at Day 28 (i.e., Week 4)

  Baseline and Day 28

• Summary Side Effect Score at Day 28 (i.e., Week 4)

  Day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.

Drug: Placebo

Donepezil

EXPERIMENTAL

Participants are instructed to take one 5mg pill (donepezil HCL \[Aricept®\]) every night before going to bed with a glass of water for 28 days.

Drug: Donepezil

Interventions

Donepezil DRUG

Also known as: Aricept

Donepezil

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Benjamin Albelda (Project Manager)
• Organization: Center for Interdisciplinary Research on Nicotine Addiction

albeldab@pennmedicine.upenn.edu

215-746-7173

Study Officials

• Andrew Strasser, MBBS, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: December 1, 2010
• Study Start: January 11, 2011
• Primary Completion: December 6, 2011
• Study Completion: December 6, 2011
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-07

Locations

US (1)