Impact of Semaglutide on Tobacco Use and Related Health Behaviors
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This pilot randomized trial will assess the impact of 12 weeks of semaglutide administration (vs placebo) on changes in: (i) tobacco use and related factors (nicotine craving, withdrawal, motivation to quit, etc.) and (ii) biological biomarkers of health (e.g., epigenetics, glucose variability via continuous glucose monitoring \[CGM\], etc.) in adult smokers with obesity (n = 40). We will integrate molecular biology procedures (e.g., epigenetics) to maximize internal validity with real-world smartphone-based ecological momentary assessment (EMA) surveys to maximize external validity
Sponsor: University of Oklahoma
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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:
Where it's recruiting
Oklahoma City
Source: ClinicalTrials.gov · NCT06986993 · last updated 2025-08-27