NCT05610800

Exenatide for Smoking Cessation and Prevention of Weight Gain

A Randomized Controlled Trial of Exenatide as an Adjunct to Nicotine Patch for Smoking Cessation and Prevention of Post-Cessation Weight Gain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Smoking Cessation
• Weight Gain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-07
• Primary completion: 2025-11-07
• Completion: 2026-03-10
• First posted: 2022-11-09
• Last updated: 2026-03-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study