Exenatide for Smoking Cessation and Prevention of Weight Gain

PHASE2RecruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

December 7, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

May 31, 2026

Conditions
Smoking CessationWeight Gain
Interventions
DRUG

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.

DRUG

Placebo

Sterile saline (0.9%) will serve as the placebo for exenatide. The placebo will be administered 2 mg subcutaneously using insulin syringes.

DRUG

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."

BEHAVIORAL

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.

Trial Locations (2)

77030

RECRUITING

Michael E. DeBakey VA Medical Center, Houston

77054

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER