Trial Outcomes & Findings for Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction (NCT NCT01876810)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

1 week in each phase

Results posted on

2017-04-20

Participant Flow

1 participant was excluded after enrollment after disclosure of a mental illness which is an exclusion criteria.

Participant milestones

Participant milestones
Measure	Gemfibrozil/Placebo 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	Placebo/Gemfibrozil 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.
Overall Study STARTED	14	14
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemfibrozil/Placebo 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	Placebo/Gemfibrozil 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.
Overall Study Physician Decision	0	1

Baseline Characteristics

Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=27 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week in each phase

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

Outcome measures

Outcome measures
Measure	Gemfibrozil n=27 Participants 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 .	Placebo n=27 Participants 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.
Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks	0.2 days Standard Error 0.1	0 days Standard Error 0

SECONDARY outcome

Timeframe: during the lab forced choice paradigm after 1 week of treatment

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.

Outcome measures

Outcome measures
Measure	Gemfibrozil n=27 Participants 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 .	Placebo n=27 Participants 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.
The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment	0.775 percentage of choice of nicotinized ciga Standard Error 0.034	0.77 percentage of choice of nicotinized ciga Standard Error 0.05

OTHER_PRE_SPECIFIED outcome

Timeframe: during the lab Cue- reactivity paradigm after 1 week of treatment

Population: 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

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.

Outcome measures

Outcome measures
Measure	Gemfibrozil n=27 Participants 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 .	Placebo n=27 Participants 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.
Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment	51 units on a scale: from 0-100 mm Standard Error 32.7	44 units on a scale: from 0-100 mm Standard Error 27.4

Adverse Events

Gemfibrozil/Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo/Gemfibrozil

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gemfibrozil/Placebo n=14 participants at risk 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	Placebo/Gemfibrozil n=13 participants at risk 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
Nervous system disorders Headache	21.4% 3/14 • Number of events 3 • 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.	0.00% 0/13 • 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.
Gastrointestinal disorders Change in appetite	14.3% 2/14 • Number of events 2 • 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.	30.8% 4/13 • Number of events 4 • 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.
Gastrointestinal disorders stomach upset	21.4% 3/14 • Number of events 3 • 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.	15.4% 2/13 • Number of events 2 • 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.

Additional Information

Bernard LeFoll

Centre for Addiction and Mental Health

Phone: 416-535-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place