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GLP-1 Receptor Agonist
Exenatide for Smoking Cessation
Phase 2
Recruiting
Led By Luba Yammine, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Summary
This trial looks at if a drug can help smokers quit and prevent weight gain afterwards.
Who is the study for?
Adults aged 18-75 who smoke at least 5 cigarettes daily for a year, want to quit within a month, have stable vital signs and HbA1C levels between 5.7-6.4%, or BMI ≥25 kg/m2. Women must use birth control and not be pregnant. Excludes those with certain mental health disorders, substance abuse issues, severe diseases like diabetes or cardiovascular conditions, or using weight management drugs.
What is being tested?
The trial is testing if exenatide helps smokers quit while preventing weight gain after quitting compared to placebo. Participants also receive nicotine patches and smoking cessation counseling to support their efforts in quitting smoking.
What are the potential side effects?
Exenatide may cause digestive issues such as nausea or vomiting, rare pancreatitis risk, possible injection site reactions, and changes in blood sugar levels which could affect appetite and body weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Secondary study objectives
Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Exenatide, NRT, and Smoking Cessation CounselingActive Control3 Interventions
Participants will receive once weekly exenatide injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.
Group II: Placebo, NRT, and Smoking Cessation CounselingPlacebo Group3 Interventions
Participants will receive once weekly saline injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,369 Total Patients Enrolled
29 Trials studying Obesity
15,300 Patients Enrolled for Obesity
Luba Yammine, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
284 Total Patients Enrolled
1 Trials studying Obesity
197 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot speak or understand English well.I have a serious heart condition.I have a severe stomach or intestine condition.I have had pancreatitis before or am at risk for it.I am between 18 and 75 years old.I am a woman who can have children and have a negative pregnancy test.I am currently taking medication to lower my blood sugar.I am currently trying to quit smoking with a program or medication.I am not pregnant, planning to become pregnant, breastfeeding, or if capable of becoming pregnant, I am using contraception.I have diabetes (type 1 or type 2).My HbA1C levels are between 5.7 and 6.4%, and/or my BMI is 25 or higher.I plan to quit smoking within the next month.I or my family have a history of medullary thyroid cancer or MEN2.I agree to use birth control as required.My doctor agrees I'm fit for the study based on my health history and a quick check-up.My kidney function is very low or I have end-stage kidney disease.I am currently in a weight management program or taking weight management medication.I agree to use effective birth control during and 7 days after the study.I plan to quit smoking within a month.
Research Study Groups:
This trial has the following groups:- Group 1: Exenatide, NRT, and Smoking Cessation Counseling
- Group 2: Placebo, NRT, and Smoking Cessation Counseling
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05610800 — Phase 2
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