Smoking CessationPhase 2NCT05610800
Exenatide for Smoking Cessation and Prevention of Weight Gain
A Phase 2 study testing Exenatide 2 milligram (mg) Injection, Nicotine patch and Smoking Cessation Counseling in people with Smoking Cessation and Weight Gain, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Weight Gain
- What is being tested?
- Exenatide 2 milligram (mg) Injection, Nicotine patch and Smoking Cessation Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2022to 10 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be willing and able to sign and date an informed consent form, willing to comply with all study procedures, and be available for the duration of the study
- Male or female, 18-75 years of age
- Have been smoking ≥5 cigarettes per day for at least 1 year and provide positive cotinine test
- Desire to quit smoking (defined as "intend to quit within one month")
- Have HbA1C levels between 5.7 and 6.4% and/or a body mass index of ≥25 kg/m2
- Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic
Show all 10Show fewer
- Have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits
- Agree (if the subject is female and of child-bearing potential) to use at least one of the following methods of birth control from time of the first administration of the study medication to at least 7 days post the last dose of the study medication, unless the partner is surgically sterile (underwent vasectomy): oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, hormonal vaginal contraceptive ring, or complete abstinence from sexual intercourse.
- Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization
- Have a medical history and a brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the Study Physician and the PI.
Who cannot join
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months (existing diagnosis or as determined by the structured interview)
- Currently using chewing tobacco, snuff, snus or electronic cigarettes
- Currently enrolled in a smoking cessation program/research study or using pharmacotherapy for smoking cessation (NRT, varenicline, or bupropion)
- Currently enrolled in a behavioral weight management plan/research study, or taking medication used for weight management (i.e., orlistat, lorcaserin,*naltrexone-bupropion, liraglutide, phentermine, benzhetamine, diethylpropion, phendimetrazine), or medication known to impact weight (i.e., corticosteroids) *Note: Withdrawn from the market in Feb 2020, but some patients may still be taking it
- Currently using oral or injectable glucose lowering medications
- Urine drug test positive, before randomization, for any of the following substances: benzodiazepines, cocaine, opioids,*amphetamines, methamphetamine, buprenorphine, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA), and/or THC. *Note: If positive for opioids or oxycodone but recent opioid use for acute pain is reported by the study candidate, then the candidate can be included at the discretion of the Primary Investigator and/or Study Physician
Show all 19Show fewer
- Psychotic or bipolar disorder, or mood disorder with psychotic features, or eating disorder (existing diagnosis or as determined by the structured interview)
- Moderate to high risk for suicidality (as determined by the structured interview)
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C level of ≥6.5%)
- Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris)
- Severe gastrointestinal disease (i.e., severe gastroparesis)
- Previous history of pancreatitis or risk of pancreatitis
- Creatinine clearance <45 mL/min or end stage renal disease (ESRD)
- Previous medically adverse reaction to the study medications or nicotine
- Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception. Medically accepted forms of contraception are specified in the inclusion criterion 8.
- Current, anticipated, or pending enrollment in another research study over the next 6 months that could potentially affect subject safety and/or the study data/design as determined by the PI and/or Study Physician
- Unable to communicate (read, write, and speak) fluently in English
- Have any illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
About this study
Official title: A Randomized Controlled Trial of Exenatide as an Adjunct to Nicotine Patch for Smoking Cessation and Prevention of Post-Cessation Weight Gain
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
- Being tested
- Exenatide 2 milligram (mg) Injection, Placebo, Nicotine patch, Smoking Cessation Counseling
- Keywords
- Smoking, Cigarettes, Nicotine, Cigarette Smoking, Weight Gain Prevention, Post-cessation Weight Gain
- Medical subject headings
- Smoking Cessation, Weight Gain, Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide 2 milligram (mg) InjectionDrug
Also called Bydureon
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.
PlaceboDrug
Sterile saline (0.9%) will serve as the placebo for exenatide. The placebo will be administered 2 mg subcutaneously using insulin syringes.
Nicotine patchDrug
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide, NRT, and Smoking Cessation Counseling | Active comparator | Participants will receive once weekly exenatide injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions. Receives: Drug: Exenatide 2 milligram (mg) Injection; Drug: Nicotine patch; Behavioral: Smoking Cessation Counseling |
| Placebo, NRT, and Smoking Cessation Counseling | Placebo comparator | Participants will receive once weekly saline injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions. Receives: Drug: Placebo; Drug: Nicotine patch; Behavioral: Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Abstinence is defined as no smoking, not even a puff, as reported on TLFB between weeks 11 through 14 and biochemically verified (CO ≤ 5 ppm) at each visit.
Measured: Week 15
Weight change in kilograms at 12 weeks post-target quit day
Measured: Baseline, Week 15
Secondary outcomes (3)
Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Abstinence is defined as no smoking, not even a puff, as reported on TLFB between weeks 22 through 25 and biochemically verified (CO ≤ 5 ppm) at Week 26.
Measured: Week 26
Weight change in kilograms at 24 weeks post-target quit day
Measured: Baseline, Week 26
Change in amplitude of the late positive potential evoked by visual stimuli
Measured: Week 1, Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start7 Dec 2022
- Primary completion7 Nov 2025
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luba Yammine, The University of Texas Health Science Center, Houston
- Investigators
- Luba Yammine, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610800
- Sponsor's protocol ID
- HSC-MS-21-0639
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herman RJ, Schmidt HD. Targeting GLP-1 receptors to reduce nicotine use disorder: Preclinical and clinical evidence. Physiol Behav. 2024 Jul 1;281:114565. doi: 10.1016/j.physbeh.2024.114565. Epub 2024 Apr 23.
PubMed 38663460Yammine L, Verrico CD, Versace F, Webber HE, Suchting R, Weaver MF, Kosten TR, Alibhai H, Cinciripini PM, Lane SD, Schmitz JM. Exenatide as an adjunct to nicotine patch for smoking cessation and prevention of postcessation weight gain among treatment-seeking smokers with pre-diabetes and/or overweight: study protocol for a randomised, placebo-controlled clinical trial. BMJ Open. 2023 Jun 14;13(6):e072707. doi: 10.1136/bmjopen-2023-072707.
PubMed 37316311
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Exenatide as an Adjunct to Nicotine Patch for Smoking Cessation and Prevention of Post-Cessation Weight Gain
- ClinicalTrials.gov ID
- NCT05610800
- Acronym / sponsor ID
- HSC-MS-21-0639
- Conditions
- Smoking Cessation, Weight Gain
- Keywords
- Smoking, Cigarettes, Nicotine, Cigarette Smoking, Weight Gain Prevention, Post-cessation Weight Gain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide, NRT, and Smoking Cessation Counseling | Active comparator | Drug: Exenatide 2 milligram (mg) Injection, Drug: Nicotine patch, Behavioral: Smoking Cessation CounselingParticipants will receive once weekly exenatide injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions. |
| Placebo, NRT, and Smoking Cessation Counseling | Placebo comparator | Drug: Placebo, Drug: Nicotine patch, Behavioral: Smoking Cessation CounselingParticipants will receive once weekly saline injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to sign and date an informed consent form, willing to comply with all study procedures, and be available for the duration of the study
- Male or female, 18-75 years of age
- Have been smoking ≥5 cigarettes per day for at least 1 year and provide positive cotinine test
- Desire to quit smoking (defined as "intend to quit within one month")
- Have HbA1C levels between 5.7 and 6.4% and/or a body mass index of ≥25 kg/m2
Key exclusion criteria (19 listed)
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months (existing diagnosis or as determined by the structured interview)
- Currently using chewing tobacco, snuff, snus or electronic cigarettes
- Currently enrolled in a smoking cessation program/research study or using pharmacotherapy for smoking cessation (NRT, varenicline, or bupropion)
- Currently enrolled in a behavioral weight management plan/research study, or taking medication used for weight management (i.e., orlistat, lorcaserin,*naltrexone-bupropion, liraglutide, phentermine, benzhetamine, diethylpropion, phendimetrazine), or medication known to impact weight (i.e., corticosteroids) *Note: Withdrawn from the market in Feb 2020, but some patients may still be taking it
- Currently using oral or injectable glucose lowering medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide 2 milligram (mg) InjectionAlso: BydureonExenatide 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 | Exenatide, NRT, and Smoking Cessation Counseling |
| PlaceboSterile saline (0.9%) will serve as the placebo for exenatide. The placebo will be administered 2 mg subcutaneously using insulin syringes. | Drug | Placebo, NRT, and Smoking Cessation Counseling |
| Nicotine patchNicotine 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. | Drug | Exenatide, NRT, and Smoking Cessation Counseling, Placebo, NRT, and Smoking Cessation Counseling |
| Smoking Cessation CounselingParticipants 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. | Behavioural | Exenatide, NRT, and Smoking Cessation Counseling, Placebo, NRT, and Smoking Cessation Counseling |
Primary outcome
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Time frame: Week 15
Abstinence is defined as no smoking, not even a puff, as reported on TLFB between weeks 11 through 14 and biochemically verified (CO ≤ 5 ppm) at each visit.
Weight change in kilograms at 12 weeks post-target quit day
Time frame: Baseline, Week 15
3 secondary outcomes
Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Time frame: Week 26
Weight change in kilograms at 24 weeks post-target quit day
Time frame: Baseline, Week 26
Change in amplitude of the late positive potential evoked by visual stimuli
Time frame: Week 1, Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 38663460Herman RJ, Schmidt HD. Targeting GLP-1 receptors to reduce nicotine use disorder: Preclinical and clinical evidence. Physiol Behav. 2024 Jul 1;281:114565. doi: 10.1016/j.physbeh.2024.114565. Epub 2024 Apr 23.
- Derived from this study: PubMed 37316311Yammine L, Verrico CD, Versace F, Webber HE, Suchting R, Weaver MF, Kosten TR, Alibhai H, Cinciripini PM, Lane SD, Schmitz JM. Exenatide as an adjunct to nicotine patch for smoking cessation and prevention of postcessation weight gain among treatment-seeking smokers with pre-diabetes and/or overweight: study protocol for a randomised, placebo-controlled clinical trial. BMJ Open. 2023 Jun 14;13(6):e072707. doi: 10.1136/bmjopen-2023-072707.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luba Yammine, PhD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide 2 milligram (mg) Injection, Nicotine patch and Smoking Cessation Counseling in people with Smoking Cessation and Weight Gain, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level (time frame: Week 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.