RECRUITING

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-07-01

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06986993

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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.

Contacts and Locations

Study Contact

Project Manager

CONTACT

405-271-1903

heal-lab@ouhsc.edu

Study Locations (Sites)

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104

United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Tobacco Use