Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06986993
Phase
PHASE4
Status
Recruiting
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Conditions

  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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

Key Dates

Start date
Jul 1, 2024
Status verified
Aug 2025
Primary completion
May 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

Cigarette smoking [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Health Promotion Research CenterOklahoma CityOklahoma73104
Research Project Coordinator
[email protected]
405-271-7759
Cohn, PhD (PRINCIPAL_INVESTIGATOR)
Oliver, PhD (SUB_INVESTIGATOR)

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Health Promotion Research Center· Oklahoma City, OK

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