Semaglutide for Tobacco Use

(ONSET Trial)

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Oklahoma

Must not be taking: Nicotine replacement, GLP-1 agonists

Disqualifiers: Schizophrenia, Bipolar, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adult smokers with obesity (BMI ≥30 kg/m2) aged 18-65 who smoke more than 2 cigarettes per day but don't immediately want to quit. It's not for those with certain medical conditions like thyroid cancer, pancreatitis, diabetes, severe psychiatric issues, or abnormal clinical labs. People on smoking cessation meds or with a history of bariatric surgery are also excluded.

Inclusion Criteria

No immediate desire to quit tobacco use (using criteria from the clinical practice guidelines for treating tobacco dependence)

My BMI is 30 or higher.

Report daily use of >2 cigarettes per day (CPD), as this is a sufficient threshold for detecting tobacco use disorder

Exclusion Criteria

I have a history of specific thyroid cancer, genetic conditions, pancreatitis, diabetes, or related complications.

I do not have severe mental health issues that would stop me from completing the study.

Clinical labs out of range/unacceptable: creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2, triglycerides > 500 mg/dl, ALP > 4x the upper normal limit, abnormal blood lipase levels, other substantially abnormal clinical lab values as determined by the Study Practitioner, A1C 6.5% or higher, Glucose >126 mL fasting or >200mg/dL random, Alanine aminotransferase (ALT) >3x upper normal limit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo injections once a week for 12 weeks to assess changes in tobacco use and related health biomarkers

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Semaglutide

Trial Overview The study tests if Semaglutide can affect tobacco use and health markers in obese smokers over 12 weeks compared to a placebo. Participants will be randomly assigned to either the drug or placebo group and monitored through smartphone surveys and biological assessments including epigenetics and glucose levels via CGM.

Participant Groups

Group I: Semaglutide Active Control 1 Intervention

Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+