Impact of Semaglutide on Tobacco Use and Related Health Behaviors

NCT06986993 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ONSET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Cigarette smoking

  Changes in number of cigarettes smoked per day

  12 weeks

Secondary Outcomes (1)

• Weight

  12 weeks

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Semaglutide DRUG

Participants are randomized to receive either semaglutide or placebo (saline) via sc injection once a week for 12 weeks. Dose will be titrated per recommendations every 4 weeks,starting at .25mg, then 0.5mg and then 1.0mg

Also known as: Ozempic

Semaglutide

Placebo DRUG

Participants are randomized to receive either semaglutide or placebo (saline) via sc injection once a week for 12 weeks. Dose will be titrated per recommendations every 4 weeks,starting at .25mg, then 0.5mg and then 1.0mg

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65;
• 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;
• meet criteria for obesity (BMI ≥30 kg/m2); and
• no immediate desire to quit tobacco use (using criteria form the clinical practice guidelines for treating tobacco dependence)

You may not qualify if:

• 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).
• 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;
• current use of nicotine replacement therapy or other quit smoking medication;
• history of bariatric surgery;
• 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.
• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use

Interventions

semaglutide; Sodium Chloride

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Project Manager

CONTACT

405-271-1903; heal-lab@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators are blind to the intervention condition
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blind randomized placebo-controlled trial

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 23, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)