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Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction

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ClinicalTrials.gov Identifier: NCT01876810
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: Gemfibrozil
Drug: Placebo
Enrollment 28
Recruitment Details  
Pre-assignment Details 1 participant was excluded after enrollment after disclosure of a mental illness which is an exclusion criteria.
Arm/Group Title Gemfibrozil/Placebo Placebo/Gemfibrozil
Hide Arm/Group Description Participants received 600 mg of gemfibrozil (one capsule) twice daily for two weeks. Then a washout period of 1 week of no medication. Then they received 1 capsule of placebo twice daily for 2 weeks Participants received 1 capsule of placebo for 2 weeks. Then a washout period of 1 week of no medication. Then they received 600 mg of gemfibrozil (one capsule) twice daily for two weeks.
Period Title: Overall Study
Started 14 14
Completed 14 13
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Arm/Group Title All Study Participants
Hide Arm/Group Description

600 mg of gemfibrozil (one capsule) twice daily for two weeks.

Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks. or One lactose pill twice a day for two weeks.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
10
  37.0%
Male
17
  63.0%
1.Primary Outcome
Title Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks
Hide Description the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide < 5 ppm
Time Frame 1 week in each phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemfibrozil Placebo
Hide Arm/Group Description:
Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period .
Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period.
Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: days
0.2  (0.1) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments For all analyses, results are considered significant at p<.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments For all analyses, results were considered significant at p< 0.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment
Hide Description

Percentage of choice of Nicotinized cigarettes was calculated for each participant during the lab session which took place after 1 week of treatment.

Each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were asked to complete some questionnaires at baseline. Then, they were asked to relax for 30 min listening to music or reading. Four exposure trials followed that were separated by 30 min of relaxation. In each exposure trial, participants took four puffs of a Nicotinized (A) or Denicotinized (less than 0.05 mg nicotine.) (B) cigarette in the order of ABAB or BABA. Cigarettes were color-coded. Participants then began four choice trials separated by 30 min of relaxation. In each trial, participants chose any combination of 4 puffs from the two cigarettes.

Time Frame during the lab forced choice paradigm after 1 week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemfibrozil Placebo Group
Hide Arm/Group Description:
Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: percentage of choice of nicotinized ciga
0.775  (0.034) 0.77  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments For all analyses, results were considered significant at p< 0.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments For all analyses, results were considered significant at p< 0.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment
Hide Description In this study, each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were then seated in a comfortable chair and completed the baseline Visual Analogue Scale for craving 0-100 mm (The higher the number the more is the craving). The smoking cue was a pack of cigarettes and a lighter. Participants were instructed to light the cigarette without puffing and hold it for 30 sec while the physiological recordings were measured. Then the participant was asked to extinguish the cigarette. The neutral cue was an unsharpened pencil, a notepad, and a sharpener. Participants were instructed to sharpen the pencil and hold it as if writing for 30 sec. Participants completed the Visual Analogue Scale for craving during the cue, and 15 and 30 min after cue presentation.
Time Frame during the lab Cue- reactivity paradigm after 1 week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
participants self-reportd Visual analogue scale (0-100 mm) for craving at the time of presenting the smoking cue. The higher the number on the scale, the more is the craving
Arm/Group Title Gemfibrozil Placebo Group
Hide Arm/Group Description:
Participants taking Gemfibrozil 600 mg (one capsule twice daily) for two weeks during the 1st phase of the study or during the second phase after the washout period.
Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: units on a scale: from 0-100 mm
51  (32.7) 44  (27.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method ANOVA
Comments Repeated-measures ANOVA on Drug X Cue X Time were used
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 51.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 31.7
Estimation Comments participants self-reportd VAS craving at the time of neutral cue presentation
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments For all analyses, results were considered significant at p< 0.05
Method ANOVA
Comments Repeated-measures ANOVA on Drug X Cue X Time were used
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 43.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 26.5
Estimation Comments [Not Specified]
Time Frame The side effects were collected for each participant over six weeks from the start of treatment (2 weeks gemfibrozil/or placebo), 1 week washout period, (2 weeks gemfibrozil/or placebo), and 1 week after completion of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemfibrozil/Placebo Placebo/Gemfibrozil
Hide Arm/Group Description

600 mg of gemfibrozil (one capsule) twice daily for two weeks.

Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of placebo twice daily for 2 weeks

One lactose pill twice a day for two weeks.

Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of gemfibrozil twice daily for 2 weeks

All-Cause Mortality
Gemfibrozil/Placebo Placebo/Gemfibrozil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
Gemfibrozil/Placebo Placebo/Gemfibrozil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemfibrozil/Placebo Placebo/Gemfibrozil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/14 (57.14%)      6/13 (46.15%)    
Gastrointestinal disorders     
Change in appetite   2/14 (14.29%)  2 4/13 (30.77%)  4
stomach upset   3/14 (21.43%)  3 2/13 (15.38%)  2
Nervous system disorders     
Headache   3/14 (21.43%)  3 0/13 (0.00%)  0
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: Bernard LeFoll
Organization: Centre for Addiction and Mental Health
Phone: 416-535-8501 ext 34772
EMail: bernard.lefoll@camh.ca
Layout table for additonal information
Responsible Party: Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01876810    
Obsolete Identifiers: NCT01900145
Other Study ID Numbers: 082/2012
First Submitted: June 6, 2013
First Posted: June 13, 2013
Results First Submitted: December 21, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017