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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Weight change in kilograms at 12 weeks post-target quit day
Secondary outcome measures
Change in amplitude of the late positive potential evoked by visual stimuli
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
Weight change in kilograms at 24 weeks post-target quit day
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
904 Previous Clinical Trials
320,744 Total Patients Enrolled
Luba Yammine, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
284 Total Patients Enrolled
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.
Smoking Cessation Patient Testimony for trial: Trial Name: NCT05610800 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this examination actively recruiting participants?
"Accurate. According to clinicaltrials.gov, the initial posting of this trial occurred on November 1st 2022 and its last update was made on November 2nd 2022; yet it is not actively enrolling patients at present. Nonetheless, there are 316 other medical studies currently seeking participants for their research endeavours."
Answered by AI
Is the current research open to participants aged seventy-five and over?
"To be included in this trial, participants must fall between the ages 18 and 75. For those under 18 years old, there are 51 studies available; for patients beyond 65 years of age, 221 research initiatives exist."
Answered by AI
Has the FDA sanctioned Exenatide, NRT, and Smoking Cessation Counseling as viable treatments?
"Taking into account the fact that this Phase 2 trial has no data confirming efficacy but some supporting safety, Exenatide, NRT and Smoking cessation Counseling received a score of two."
Answered by AI
Would I be able to participate in this experiment on human subjects?
"This clinical trial is actively seeking 216 individuals, aged 18-75 years who demonstrate weight gain. Additional criteria includes being male or female, smoking at least 5 cigarettes a day for 12 months and providing a positive cotinine test result, intending to quit within one month of the study beginning, having an HbA1C level between 5.7 - 6.4% and/or BMI ≥25 kg/m2 ,vital resting pulse rate (50-95 bpm)and BP(90-150 mmHg systolic & 45-95 diastolic), agreeing (if applicable) to use contraception from first"
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to quit smoking. I want to quit smoking and I need money. 2 birds..
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Recent research and studies
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