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Semaglutide for Nicotine Addiction

Phase 2
Recruiting
Led By Christian Hendershot, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to study endpoint (week 10)
Awards & highlights

Study Summary

This trial will examine whether a GLP-1 receptor agonist can reduce nicotine intake and reinstatement in smokers.

Who is the study for?
This trial is for adults aged 21-65 who smoke at least 5 cigarettes daily over the past year without a break of more than 90 days. Participants must have moderate nicotine dependence, be motivated to quit within the next 3-18 months, and willing to take study medication and attend lab sessions involving smoking. Exclusions include those with diabetes, certain medical conditions or histories (like cancer), uncontrolled blood pressure, extreme BMI values, use of conflicting medications or substances, and women who are pregnant or not using effective contraception.Check my eligibility
What is being tested?
The trial tests Semaglutide's effects on nicotine intake among smokers. It's a double-blind study where participants won't know if they're getting Semaglutide or a placebo. The goal is to see if this drug can help reduce cigarette consumption by affecting biological mechanisms related to addiction.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones for Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and constipation. There could also be potential allergic reactions in those sensitive to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to study endpoint (week 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to study endpoint (week 10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Nicotine Reinstatement Duration
Change in Nicotine Self-Administration
Secondary outcome measures
Change in Daily Cigarette Smoking
Other outcome measures
Change in Body Weight
Change in Cigarette Craving
Body Weight Changes
+1 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Group II: Sham/PlaceboPlacebo Group1 Intervention
Participants will receive sham subcutaneous injections over 9 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,614 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,545 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
49,019 Patients Enrolled for Tobacco Use Disorder
Christian Hendershot, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

Tobacco Use Disorder Research Study Groups: Sham/Placebo, Semaglutide

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients who have not yet been enrolled in this research project?

"Yes, this trial is recruiting patients according to the information found on clinicaltrials.gov. The listing was first put up on October 7th, 2020 and was last updated two weeks ago on October 21st, 2020."

Answered by AI

How many people are currently participating in this research?

"That is correct, the clinical trial mentioned is presently looking for 48 participants from 1 location, as per the information found on clinicaltrials.gov. The trial was initially posted on 10/7/2022 and was most recently edited on 10/21/2022."

Answered by AI

Did the FDA greenlight Semaglutide for public consumption?

"Semaglutide received a 2 for safety because, although Phase 2 trials have not yet assessed efficacy, there is some data supporting safety."

Answered by AI

Do I meet the requirements to join this test group?

"This research team is looking for 48 individuals that have nicotine dependence and are aged 21-65."

Answered by AI

Are people of all ages welcome in this trial, or are there restrictions?

"The age limit for this particular trial is 21-65, however there are 5 other trials open to people who are under 18 and 81 trials available for those who are over 65."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
Other
Maryland
What site did they apply to?
University of North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

To learn more about my smoking addiction. I have tried patches, lozenges, gum and vaping and nothing works.
PatientReceived no prior treatments
I've tried for years. Single parent and need to be here for my kids. Profesional and otherwise healthy. No other health conditions.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of North Carolina: < 48 hours
Average response time
  • < 2 Days
~19 spots leftby Apr 2025