Trial Outcomes & Findings for Gemfibrozil for Nicotine Smoking Cessation (NCT NCT02638597)
NCT ID: NCT02638597
Last Updated: 2019-02-01
Results Overview
Exhaled carbon monoxide change from baseline to last available visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
8 weeks after target quit date
Results posted on
2019-02-01
Participant Flow
Participant milestones
| Measure |
Waitlist
Participants placed on waitlist for medication, otherwise completed study procedures
|
Gemfibrozil
Received gemfibrozil tablets
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemfibrozil for Nicotine Smoking Cessation
Baseline characteristics by cohort
| Measure |
Waitlist
n=8 Participants
Participants placed on waitlist for medication, otherwise completed study procedures
|
Gemfibrozil
n=8 Participants
Received gemfibrozil tablets
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.25 Years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
37.50 Years
STANDARD_DEVIATION 22.02 • n=7 Participants
|
31.38 Years
STANDARD_DEVIATION 18.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after target quit dateExhaled carbon monoxide change from baseline to last available visit.
Outcome measures
| Measure |
Gemfibrozil
n=8 Participants
Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion
Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
smoking cessation counseling: smoking cessation counseling
|
Waitlist
n=8 Participants
Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.
smoking cessation counseling: smoking cessation counseling
|
|---|---|---|
|
Exhaled Carbon Monoxide (CO)
|
10.88 Parts p/million
Standard Deviation 12.63
|
21.63 Parts p/million
Standard Deviation 22.04
|
SECONDARY outcome
Timeframe: 8 weeks after target quit dateThe outcome measure was Heaviness of Smoking Index at exit. The Heaviness of Smoking Index is a two-item scale, with scores on each item rated on a 1-4 likert scale. The total score of the measure ranges from 2-8, with higher scores indicating worse outcome.
Outcome measures
| Measure |
Gemfibrozil
n=8 Participants
Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion
Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
smoking cessation counseling: smoking cessation counseling
|
Waitlist
n=8 Participants
Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.
smoking cessation counseling: smoking cessation counseling
|
|---|---|---|
|
Heaviness of Smoking Index
|
1.25 score on a scale
Standard Deviation 1.04
|
1.63 score on a scale
Standard Deviation 1.30
|
Adverse Events
Gemfibrozil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Waitlist
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gemfibrozil
n=8 participants at risk
Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion
Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
smoking cessation counseling: smoking cessation counseling
|
Waitlist
n=8 participants at risk
Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.
smoking cessation counseling: smoking cessation counseling
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Arm bruising
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
Additional Information
Principal Investigator
University of Texas Southwestern Medical Center
Phone: 2146480188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place