216
Participants
Start Date
December 7, 2022
Primary Completion Date
March 31, 2026
Study Completion Date
May 31, 2026
Exenatide 2 milligram (mg) Injection
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.
Placebo
Sterile saline (0.9%) will serve as the placebo for exenatide. The placebo will be administered 2 mg subcutaneously using insulin syringes.
Nicotine patch
"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."
Smoking Cessation Counseling
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.
RECRUITING
Michael E. DeBakey VA Medical Center, Houston
RECRUITING
The University of Texas Health Science Center at Houston, Houston
The University of Texas Health Science Center, Houston
OTHER