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Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Oklahoma
Health Promotion Research Center
RECRUITING
Oklahoma City
Contact Information
Primary
Project Manager
heal-lab@ouhsc.edu
405-271-1903
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Semaglutide
Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks
Placebo_comparator: Placebo
Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks
Related Therapeutic Areas
Sponsors
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov