Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06986993

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Led by University of Oklahoma · Updated on 2025-08-27

40

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 65 years
  • Daily use of more than 2 cigarettes per day
  • Meet criteria for obesity with a BMI of 30 kg/m2 or higher
  • No immediate desire to quit tobacco use according to clinical guidelines
Not Eligible

You will not qualify if you...

  • Severe psychiatric disorders including schizophrenia, schizoaffective disorder, or bipolar disorder
  • Psychiatric hospitalization in the past year
  • Suicidal ideation in the past month or suicide attempt in the past year
  • Severe depression or recent worsening of depression or anxiety symptoms
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome
  • Personal history of pancreatitis, type I or II diabetes, diabetic retinopathy, or gastroparesis
  • Current use of nicotine replacement therapy or quit-smoking medications
  • History of bariatric surgery
  • Use of GLP-1 agonists or other weight-lowering or glucose-lowering medications in the past 6 months
  • Unacceptable clinical lab results including creatinine ≥ 2 mg/dL, low eGFR, high triglycerides, abnormal liver enzymes, abnormal lipase, high A1C, or elevated glucose
  • Significant gastrointestinal disorders such as inflammatory bowel disease, gastrointestinal malignancy, severe gastroparesis, or intestinal obstruction
  • Allergy to semaglutide, its components, or other GLP-1 analogs
  • Any other condition judged by investigators to interfere with study participation or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Health Promotion Research Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

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Research Team

P

Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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