Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Launched by UNIVERSITY OF OKLAHOMA · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called semaglutide might help adults who smoke and are also living with obesity. The researchers want to see if taking semaglutide for 12 weeks can reduce tobacco use and help with issues like nicotine cravings and motivation to quit smoking. They will also check health markers, such as blood sugar levels, to see if there are any changes.

To participate, you need to be between 18 and 65 years old, smoke more than two cigarettes a day, have a body mass index (BMI) of 30 or higher (which indicates obesity), and not currently want to quit smoking. Participants will receive either semaglutide or a placebo (a non-active substance) and will be asked to report their experiences through surveys on their smartphones. It’s important to note that there are specific health conditions that may exclude someone from joining the trial, such as certain severe psychiatric disorders or recent use of other smoking cessation medications. Overall, this study could provide valuable insights into new ways to support smoking cessation among people with obesity.

Gender

ALL

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.