Using exenatide to help people quit smoking and prevent weight gain

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

This study is testing if a diabetes medication called exenatide can help people quit smoking and avoid gaining weight afterward.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT05610800 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of exenatide, a medication typically used for diabetes, in improving smoking cessation rates and preventing weight gain after quitting smoking. Participants will receive either exenatide injections or a placebo, alongside nicotine patches and smoking cessation counseling. The study will assess the end-of-treatment smoking abstinence rates and monitor any changes in weight among participants. It targets individuals who are motivated to quit smoking and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who smoke at least 5 cigarettes per day and wish to quit within a month.

Not a fit: Patients who do not smoke or are not motivated to quit smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals looking to quit smoking while managing weight gain.

How similar studies have performed: Other studies have explored the use of medications for smoking cessation, but the specific application of exenatide for this purpose is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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
* 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.

Where this trial is running

Houston, Texas and 1 other locations

• Michael E. DeBakey VA Medical Center — Houston, Texas, United States (Recruiting)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Luba Yammine, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Luba Yammine, PhD

Conditions Smoking Cessation; Weight Gain; Smoking; Cigarettes; Nicotine; Cigarette Smoking; Weight Gain Prevention; Post-cessation Weight Gain