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Trial record 96 of 331 for:    DONEPEZIL

Effect of Donepezil on Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01250977
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Smoking
Interventions Drug: Donepezil
Drug: Placebo
Enrollment 30
Recruitment Details Thirty subjects were consented and screened for eligibility at an Intake Visit at the Center for Interdisciplinary Research on Nicotine Addiction (Philadelphia, PA).
Pre-assignment Details Twenty subjects ultimately completed a Baseline Visit and were randomized to receive Donepezil or Placebo.
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days. 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.
Period Title: Overall Study
Started 6 14
Completed 6 12
Not Completed 0 2
Arm/Group Title Placebo Donepezil Total
Hide Arm/Group Description Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days. 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. Total of all reporting groups
Overall Number of Baseline Participants 6 14 20
Hide Baseline Analysis Population Description
All participants receiving at least one dose of Donepezil or Placebo are included in the analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 14 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
14
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 14 participants 20 participants
35.00  (9.58) 33.24  (10.51) 33.75  (9.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 14 participants 20 participants
Female
2
  33.3%
5
  35.7%
7
  35.0%
Male
4
  66.7%
9
  64.3%
13
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 14 participants 20 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
14
 100.0%
20
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 14 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.1%
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
5
  35.7%
5
  25.0%
White
5
  83.3%
8
  57.1%
13
  65.0%
More than one race
1
  16.7%
0
   0.0%
1
   5.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 14 participants 20 participants
6 14 20
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
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.
Overall Number of Participants Analyzed 6 12
Mean (Standard Error)
Unit of Measure: True positive responses
.59  (.88) 3.4  (.88)
2.Primary Outcome
Title Change From Baseline in Discriminability on the Penn Continuous Performance Neurocognitive Task at Day 28 (i.e., Week 4)
Hide Description 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.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
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.
Overall Number of Participants Analyzed 6 12
Mean (Standard Error)
Unit of Measure: correct minus incorrect responses
-.1  (.08) .5  (.08)
3.Secondary Outcome
Title Change From Baseline in Smoking Behavior (i.e., Cigarettes Per Day) at Day 28 (i.e., Week 4)
Hide Description At each visit, smoking rate (i.e., cigarettes per day) was assessed using standard Timeline Followback methods. Weekly averages were computed to assess group differences in changes in smoking behavior from Baseline to Day 28.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
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.
Overall Number of Participants Analyzed 6 12
Mean (Standard Error)
Unit of Measure: cigarettes per day
3.3  (4.4) 1.9  (1.0)
4.Secondary Outcome
Title Summary Side Effect Score at Day 28 (i.e., Week 4)
Hide Description A 38-item self-report measure of the side effects associated with Donepezil (e.g., nausea) was administered to all participants at observation and testing days through Day 28. For each item, side effect severity was rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe). The side effect summary score from the measure collected at Day 28 was considered the dependent measure because Day 28 is when the medication reached steady state. The side effect summary score was calculated by taking the mean score (i.e., sum of all 38 items [each item rated on a scale 0-3] divided by 38) of the measure from each participant at Day 28, adding the means, and then dividing the sum of the means by the number of participants within each group. A higher summary score indicates a higher general incidence rate and severity of side effects.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.
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.
Overall Number of Participants Analyzed 6 12
Mean (Standard Error)
Unit of Measure: score on a scale
2.3  (.7) 1.1  (.5)
Time Frame Adverse event data were collected over a 28-day period.
Adverse Event Reporting Description

The safety population described within this section includes all subjects who received at least one dose of Donepezil or Placebo.

Systematic Assessment: Side effect severity was rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe) using a 38-item self-report measure based on common side effects of Donepezil (e.g., nausea) at all in-person visits (n=9).

 
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days. 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.
All-Cause Mortality
Placebo Donepezil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Donepezil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Donepezil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      14/14 (100.00%)    
Cardiac disorders     
Chest Pain   1/6 (16.67%)  1 2/14 (14.29%)  3
Eye disorders     
Abnormal Vision   0/6 (0.00%)  0 1/14 (7.14%)  3
Eye Redness/Irritation   1/6 (16.67%)  1 4/14 (28.57%)  10
Gastrointestinal disorders     
Nausea   0/6 (0.00%)  0 3/14 (21.43%)  10
Diarrhea   0/6 (0.00%)  0 4/14 (28.57%)  8
Vomiting   0/6 (0.00%)  0 1/14 (7.14%)  1
Abdominal pain or bloating   1/6 (16.67%)  1 2/14 (14.29%)  3
Flatulence   0/6 (0.00%)  0 2/14 (14.29%)  3
Black Stool   0/6 (0.00%)  0 1/14 (7.14%)  1
General disorders     
Fatigue or tiredness   4/6 (66.67%)  14 6/14 (42.86%)  13
Decreased Appetite   0/6 (0.00%)  0 6/14 (42.86%)  10
Weight Decrease   0/6 (0.00%)  0 3/14 (21.43%)  6
Dizziness   2/6 (33.33%)  4 3/14 (21.43%)  7
Drowsiness   3/6 (50.00%)  15 7/14 (50.00%)  11
Dehydration   2/6 (33.33%)  8 3/14 (21.43%)  6
Fever   0/6 (0.00%)  0 2/14 (14.29%)  3
Hot Flashes   0/6 (0.00%)  0 1/14 (7.14%)  4
Musculoskeletal and connective tissue disorders     
Muscle Cramps   1/6 (16.67%)  1 1/14 (7.14%)  3
Body Pain (including Back Pain)   1/6 (16.67%)  3 3/14 (21.43%)  7
Joint Pain   0/6 (0.00%)  0 3/14 (21.43%)  14
Nervous system disorders     
Headache   3/6 (50.00%)  16 5/14 (35.71%)  17
Psychiatric disorders     
Insomnia   2/6 (33.33%)  10 4/14 (28.57%)  10
Depressed Mood   1/6 (16.67%)  1 1/14 (7.14%)  4
Abnormal Dreams   3/6 (50.00%)  9 8/14 (57.14%)  21
Hostility   0/6 (0.00%)  0 1/14 (7.14%)  3
Nervousness   1/6 (16.67%)  6 1/14 (7.14%)  4
Confusion   1/6 (16.67%)  1 2/14 (14.29%)  5
Renal and urinary disorders     
Frequent Urination   0/6 (0.00%)  0 4/14 (28.57%)  7
Incontinence   0/6 (0.00%)  0 1/14 (7.14%)  4
Difficulty Urinating   0/6 (0.00%)  0 1/14 (7.14%)  2
Respiratory, thoracic and mediastinal disorders     
Cough   4/6 (66.67%)  12 6/14 (42.86%)  18
Sore Throat   4/6 (66.67%)  5 5/14 (35.71%)  14
Skin and subcutaneous tissue disorders     
Large Bruises   0/6 (0.00%)  0 1/14 (7.14%)  1
Itching   0/6 (0.00%)  0 2/14 (14.29%)  5
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin Albelda (Project Manager)
Organization: Center for Interdisciplinary Research on Nicotine Addiction
Phone: 215-746-7173
EMail: albeldab@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01250977     History of Changes
Other Study ID Numbers: UPCC 12910
First Submitted: October 20, 2010
First Posted: December 1, 2010
Results First Submitted: April 16, 2019
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019