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Exenatide for Smoking Cessation and Prevention of Weight Gain

NCT05610800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Luba Yammine, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2025-11-07
Completion
2026-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610800 on ClinicalTrials.gov