Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Description

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

Study Overview

Study Details

Study overview

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

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

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Condition
Tobacco Use
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

Health Promotion Research Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Severe psychiatric disturbance precluding successful completion of the study, defined as
  • 2. 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;
  • 3. current use of nicotine replacement therapy or other quit smoking medication;
  • 4. history of bariatric surgery;
  • 5. 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.
  • 6. Clinical labs out of range/unacceptable:
  • 1. creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2,
  • 2. triglycerides\> 500 mg/dl,
  • 3. ALP \> 4x the upper normal limit,
  • 4. abnormal blood lipase levels,
  • 5. other substantially abnormal clinical lab values as determined by the Study Practitioner
  • 6. A1C 6.5% or higher
  • 7. Glucose \>126 mL fasting or \>200mg/dL random
  • 8. Alanine aminotransferase (ALT) \>3x upper normal limit
  • 7. History of significant gastrointestinal disorder, including inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if in remission), diverticular disease, severe gastroparesis, diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele, intestinal or colonic obstruction, or suspected intestinal obstruction, intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), pancreatitis, active biliary disease
  • 8. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a possible subject.
  • 9. Known or suspected allergy to semaglutide, any of the product components, or any other GLP-1 analogue.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Study Record Dates

2028-06-30