Impact of Semaglutide on Tobacco Use and Related Health Behaviors
Recruiting
Phase 4Interventional Study
Tobacco Use
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
University of Oklahoma · Other
Who this trial is looking for
This trial is looking for adult smokers with obesity who want to understand how semaglutide affects tobacco use and related health factors. Participants will take semaglutide or a placebo for 12 weeks while their health behaviors and biological markers are monitored.
Are You a Good Fit for This Trial?
Rules you outSevere psychiatric disturbancePancreatitisMedullary thyroid carcinomaMultiple endocrine neoplasia syndrome
You may be able to join if
I am aged 18-65.
I smoke more than 2 cigarettes a day.
I have a body mass index (BMI) of 30 or higher.
I do not want to quit smoking right now.
You may not be able to join if
I have severe psychiatric issues that prevent me from completing the study.
I have a personal or family history of certain thyroid or endocrine conditions.
I currently use nicotine replacement therapy or other smoking cessation medications.
I have had weight-loss surgery.
I have used specific weight-lowering or diabetes medications in the last 6 months.
My blood tests show serious abnormalities.
I have a significant gastrointestinal disorder.
I have an allergy to semaglutide or similar medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 integrat…
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
Trial Locations
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Status
Eligibility Criteria
Inclusion criteria :
1. Aged 18-65;
2. 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;
3. meet criteria for obesity (BMI ≥30 kg/m2); and
4. no immediate desire to quit tobacco use (using crite…
Inclusion criteria :
1. Aged 18-65;
2. 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;
3. meet criteria for obesity (BMI ≥30 kg/m2); and
4. no immediate desire to quit tobacco use (using criteria form the clinical practice guidelines for treating tobacco dependence)
Exclusion criteria:
1. Severe psychiatric disturbance precluding successful completion of the study, defined as
a. Ever schizophrenia, schizoaffective disorder, or bipolar disorder (assessed at the screener and again at baseline); b. Psychiatric hospitalization in the past year (assessed at the screener and again at baseline); c. Suicidal ideation in the past month or any past year suicide attempt (assessed at baseline) i. Suicidal ideation determined by the Ask Suicide Screening Questions (ASQ) Question 1-3 ii. Any suicide attempts in the past year (ASQ 4) iii. Suicidal intent and plan (ASQ 5) iv. PHQ-9 score of 20 or higher, indicating severe depression or PHQ-9 score of 15 or higher if participant also indicates worsening of symptoms in the past 3 months.
v. Worsening symptoms of depression or anxiety in the past 3-months (as determined by Medical History Questionnaire).
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.
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