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Gemfibrozil for Nicotine Smoking Cessation (GEMNIC)

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: NCT02638597
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Drug: Gemfibrozil
Behavioral: smoking cessation counseling
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Waitlist Gemfibrozil
Hide Arm/Group Description Participants placed on waitlist for medication, otherwise completed study procedures Received gemfibrozil tablets
Period Title: Overall Study
Started 8 8
Completed 4 3
Not Completed 4 5
Arm/Group Title Waitlist Gemfibrozil Total
Hide Arm/Group Description Participants placed on waitlist for medication, otherwise completed study procedures Received gemfibrozil tablets Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
25.25  (14.12) 37.50  (22.02) 31.38  (18.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
6
  75.0%
6
  75.0%
12
  75.0%
Male
2
  25.0%
2
  25.0%
4
  25.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8
 100.0%
8
 100.0%
16
 100.0%
1.Primary Outcome
Title Exhaled Carbon Monoxide (CO)
Hide Description Exhaled carbon monoxide change from baseline to last available visit.
Time Frame 8 weeks after target quit date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemfibrozil Waitlist
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Parts p/million
10.88  (12.63) 21.63  (22.04)
2.Secondary Outcome
Title Heaviness of Smoking Index
Hide Description The 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.
Time Frame 8 weeks after target quit date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Waitlist Gemfibrozil
Hide Arm/Group Description:
Participants placed on waitlist for medication, otherwise completed study procedures
Received gemfibrozil tablets
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.25  (1.04) 1.63  (1.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemfibrozil Waitlist
Hide Arm/Group Description

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

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

All-Cause Mortality
Gemfibrozil Waitlist
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemfibrozil Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemfibrozil Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      1/8 (12.50%)    
Gastrointestinal disorders     
Abdominal pain  [1]  1/8 (12.50%)  1 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders     
Arm bruising * [2]  0/8 (0.00%)  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Ended up being gallbladder disease.
[2]
Arm bruising as a result of study-related blood draw.
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: Principal Investigator
Organization: University of Texas Southwestern Medical Center
Phone: 2146480188
EMail: madhukar.trivedi@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02638597     History of Changes
Other Study ID Numbers: STU 072014-088
First Submitted: December 18, 2015
First Posted: December 23, 2015
Results First Submitted: November 30, 2018
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019