Exenatide for Smoking Cessation and Prevention of Weight Gain

What this study is testing ClinicalTrials.gov NCT05610800 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Exenatide 2 milligram (mg) Injection also known as Bydureon Drug

  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 Drug

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

• Nicotine patch Drug

  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 Behavioral

  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.