The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Exenatide will be purchased commercially as Bydureon for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 14 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Sterile saline (0.9%) will serve as the placebo for exenatide. The placebo will be administered 2 mg subcutaneously using insulin syringes.
Nicotine patches will be purchased commercially and dispensed during clinic visits for one week of use. Participants who smoke \>10 cigarettes/day will receive 21 mg patches for the first 12 weeks, 14 mg patches for week 13, and 7 mg patches for week 14. Participants who smoke 5-10 cigarettes per day will receive 14 mg patches for the first 12 weeks and 7 mg patches for weeks 13 and 14.
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Abstinence is defined as no smoking, not even a puff, as reported on TLFB between weeks 11 through 14 and biochemically verified (CO ≤ 5 ppm) at each visit.
Time frame: Week 15
Weight change in kilograms at 12 weeks post-target quit day
Time frame: Baseline, Week 15
Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Abstinence is defined as no smoking, not even a puff, as reported on TLFB between weeks 22 through 25 and biochemically verified (CO ≤ 5 ppm) at Week 26.
Time frame: Week 26
Weight change in kilograms at 24 weeks post-target quit day
Time frame: Baseline, Week 26
Change in amplitude of the late positive potential evoked by visual stimuli
Time frame: Week 1, Week 3
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Participants will receive brief individual behavioral smoking cessation counseling that consist of weekly in-person sessions and 2 brief (10-15 min) supportive phone calls (once pre-quit and again 3-days post-quit), spanning the 14-week active treatment phase. Counseling will be provided by master's level clinicians who will receive at least 8 hours of initial training.