Tobacco UsePhase 4ONSETNCT06986993
Impact of Semaglutide on Tobacco Use and Related Health Behaviors
A Phase 4 study testing Semaglutide in people with Tobacco Use, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe psychiatric disturbance precluding successful completion of the study, defined as
- 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.
- Worsening symptoms of depression or anxiety in the past 3-months (as determined by Medical History Questionnaire).
- 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;
- current use of nicotine replacement therapy or other quit smoking medication;
- history of bariatric surgery;
Show all 19Show fewer
- 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.
- Clinical labs out of range/unacceptable:
- creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2,
- triglycerides> 500 mg/dl,
- ALP > 4x the upper normal limit,
- abnormal blood lipase levels,
- other substantially abnormal clinical lab values as determined by the Study Practitioner
- A1C 6.5% or higher
- Glucose >126 mL fasting or >200mg/dL random
- Alanine aminotransferase (ALT) >3x upper normal limit
- 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
- Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a possible subject.
- Known or suspected allergy to semaglutide, any of the product components, or any other GLP-1 analogue.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
Research Project Coordinator, 405-271-7759, heal-lab@ouhsc.edu
Cohn, PhD
About this study
Official title: Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity
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
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic
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
PlaceboDrug
Also called Saline
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 group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette smoking
Changes in number of cigarettes smoked per day
Measured: 12 weeks
Secondary outcomes (1)
Weight
change in weight (in lbs)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jul 2024
- Primary completion30 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind randomized placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986993
- Sponsor's protocol ID
- ONSET
- Acronym
- ONSET
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small-scale feasibility study with very limited resources to manage data sharing and support efforts by other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity
- ClinicalTrials.gov ID
- NCT06986993
- Acronym / sponsor ID
- ONSET / ONSET
- Conditions
- Tobacco Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double blind randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: SemaglutideParticipants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- Severe psychiatric disturbance precluding successful completion of the study, defined as
- 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;
- current use of nicotine replacement therapy or other quit smoking medication;
- history of bariatric surgery;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: OzempicParticipants 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 | Drug | Semaglutide |
| PlaceboAlso: SalineParticipants 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 | Drug | Placebo |
Primary outcome
Cigarette smoking
Time frame: 12 weeks
Changes in number of cigarettes smoked per day
1 secondary outcome
Weight
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No. This is a small-scale feasibility study with very limited resources to manage data sharing and support efforts by other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Tobacco Use, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (405-271-1903, heal-lab@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette smoking (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.