Effects of Semaglutide on Smoking and Health in Obese Adults

Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity

This study is testing if a medication called semaglutide can help obese adults who smoke reduce their cravings and improve their health over 12 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT06986993 on ClinicalTrials.gov

What this trial studies

This pilot trial investigates the effects of 12 weeks of semaglutide treatment compared to a placebo on tobacco use and related health behaviors in adult smokers with obesity. The study will measure changes in nicotine craving, withdrawal symptoms, motivation to quit, and biological health markers such as glucose variability and epigenetic factors. Participants will engage in smartphone-based surveys to provide real-time data on their smoking behaviors and health status, enhancing the study's validity. A total of 40 adult smokers who meet specific criteria will be enrolled.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who smoke more than 2 cigarettes per day and have a BMI of 30 or higher without an immediate desire to quit smoking.

Not a fit: Patients with severe psychiatric disorders or those who have recently attempted suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach to help obese smokers reduce tobacco use and improve their overall health.

How similar studies have performed: While there is limited data on the specific use of semaglutide for tobacco cessation, similar interventions targeting smoking cessation have shown promise in other studies.

Eligibility criteria

Inclusion criteria :

1. Aged 18-65;
2. report daily use of \>2 cigarettes per day (CPD), as this is a sufficient threshold for detecting tobacco use disorder, per MPI Oliver's published work57;
3. meet criteria for obesity (BMI ≥30 kg/m2); and
4. no immediate desire to quit tobacco use (using criteria form the clinical practice guidelines for treating tobacco dependence)

Exclusion criteria:

1. Severe psychiatric disturbance precluding successful completion of the study, defined as

   a. Ever schizophrenia, schizoaffective disorder, or bipolar disorder (assessed at the screener and again at baseline); b. Psychiatric hospitalization in the past year (assessed at the screener and again at baseline); c. Suicidal ideation in the past month or any past year suicide attempt (assessed at baseline) i. Suicidal ideation determined by the Ask Suicide Screening Questions (ASQ) Question 1-3 ii. Any suicide attempts in the past year (ASQ 4) iii. Suicidal intent and plan (ASQ 5) iv. PHQ-9 score of 20 or higher, indicating severe depression or PHQ-9 score of 15 or higher if participant also indicates worsening of symptoms in the past 3 months.

   v. Worsening symptoms of depression or anxiety in the past 3-months (as determined by Medical History Questionnaire).
2. personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, and personal history of pancreatitis, type I or type II diabetes, diabetic retinopathy, or gastroparesis;
3. current use of nicotine replacement therapy or other quit smoking medication;
4. history of bariatric surgery;
5. Current or past 6-month use of a GLP-1 agonist or any other weight-lowering/anti-obesity or glucose-lowering medications. These include (but are not limited to: sulfonylurea, insulin, metformin, thiazolidinediones (TZD), dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or GLP-1 analogs.
6. Clinical labs out of range/unacceptable:

   1. creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2,
   2. triglycerides\> 500 mg/dl,
   3. ALP \> 4x the upper normal limit,
   4. abnormal blood lipase levels,
   5. other substantially abnormal clinical lab values as determined by the Study Practitioner
   6. A1C 6.5% or higher
   7. Glucose \>126 mL fasting or \>200mg/dL random
   8. Alanine aminotransferase (ALT) \>3x upper normal limit
7. History of significant gastrointestinal disorder, including inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if in remission), diverticular disease, severe gastroparesis, diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele, intestinal or colonic obstruction, or suspected intestinal obstruction, intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), pancreatitis, active biliary disease
8. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a possible subject.
9. Known or suspected allergy to semaglutide, any of the product components, or any other GLP-1 analogue.

Where this trial is running

Oklahoma City, Oklahoma

• Health Promotion Research Center — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Study coordinator: Project Manager

Conditions Tobacco Use