Smoking CessationPhase 1/2NCT02975297

Exenatide Once Weekly for Smoking Cessation

A Phase 1/2 study testing Exenatide, NRT and Counseling in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to identify a potential new treatment for smoking cessation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Smoking Cessation
What is being tested?: Exenatide, NRT and Counseling
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteUnited States
Study dates: Jul 2016to 3 Jan 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;
Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;
Have a negative pregnancy test, if female of childbearing potential;
Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters
Not currently using any therapy for glycemic control (either injectable [i.e. insulin] or oral agents);
Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic;
Have hematology and chemistry laboratory tests that are within reference limits (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits;
Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator.

Who cannot join

Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features).
Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician.
Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI.
Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
Have type 1 diabetes mellitus;
Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris);

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Have active temporomandibular joint disease;
Have severe gastrointestinal disease (i.e. severe gastroparesis);
Have previous history of pancreatitis or are at risk for pancreatitis;
Have creatinine clearance (CrCl) < 30;
Have any previous medically adverse reaction to study medications, nicotine, or menthol;
Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry;
Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide);
Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial

The purpose of this study is to identify a potential new treatment for smoking cessation.

Conditions: Smoking Cessation
Being tested: Exenatide, NRT, Counseling, Placebo
Keywords: smoking, pre-diabetes, overweight, exenatide, Glucagon-like peptide-1 (GLP-1) agonists
Medical subject headings: Smoking Cessation, Smoking, Glucose Intolerance, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExenatideDrug
Also called Bydureon
Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRTDrug
Also called Nicotine patch
Nicotine Patch (21mg) / 24 hours.
CounselingBehavioural
Also called Smoking cessation counseling
Brief individual behavioral smoking cessation counseling.
PlaceboDrug
Normal saline.

Study groups in NCT02975297
Study group	Role	What they receive
Exenatide plus NRT plus counseling	Experimental	Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Receives: Drug: Exenatide; Drug: NRT; Behavioral: Counseling
Placebo plus NRT plus counseling	Placebo comparator	Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Receives: Drug: NRT; Behavioral: Counseling; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Measured: 6 weeks
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Measured: 6 weeks
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal.
Measured: 6 weeks
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Measured: 1 week
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Measured: 3 weeks

Secondary outcomes (4)

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Measured: 7 weeks (1 week after end of treatment)
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Measured: 10 weeks (4 weeks after end of treatment)
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Measured: 7 weeks (1 week after end of treatment)
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Measured: 10 weeks (4 weeks after end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20163 Jan 2020

First posted29 Nov 2016 (estimated)
Study startJul 2016
Primary completion3 Jan 2020
Study completion3 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02975297
Sponsor's protocol ID: HSC-MS-17-0802
Other IDs: CCTS Research Scholar Award
Status last verified: Jan 2021
First submitted: 18 Nov 2016
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yammine L, Kosten TR, Cinciripini PM, Green CE, Meininger JC, Minnix JA, Newton TF. Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial. Medicine (Baltimore). 2018 Jan;97(2):e9567. doi: 10.1097/MD.0000000000009567.
PubMed 29480848
Yammine L, Green CE, Kosten TR, de Dios C, Suchting R, Lane SD, Verrico CD, Schmitz JM. Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2021 Aug 29;23(10):1682-1690. doi: 10.1093/ntr/ntab066.
PubMed 33831213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02975297
Acronym / sponsor ID: HSC-MS-17-0802
Conditions: Smoking Cessation
Keywords: smoking, pre-diabetes, overweight, exenatide, Glucagon-like peptide-1 (GLP-1) agonists
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Jul 2016 (actual)
Primary completion: 3 Jan 2020 (actual)
Study completion: 3 Jan 2020 (actual)
First posted: 29 Nov 2016 (estimated)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to identify a potential new treatment for smoking cessation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exenatide plus NRT plus counseling	Experimental	Drug: Exenatide, Drug: NRT, Behavioral: CounselingOnce weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Placebo plus NRT plus counseling	Placebo comparator	Drug: NRT, Behavioral: Counseling, Drug: PlaceboOnce weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;
Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;
Have a negative pregnancy test, if female of childbearing potential;
Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters
Not currently using any therapy for glycemic control (either injectable [i.e. insulin] or oral agents);

Key exclusion criteria (14 listed)

Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features).
Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician.
Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI.
Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
Have type 1 diabetes mellitus;

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
ExenatideAlso: BydureonExenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.	Drug	Exenatide plus NRT plus counseling
NRTAlso: Nicotine patchNicotine Patch (21mg) / 24 hours.	Drug	Exenatide plus NRT plus counseling, Placebo plus NRT plus counseling
CounselingAlso: Smoking cessation counselingBrief individual behavioral smoking cessation counseling.	Behavioural	Exenatide plus NRT plus counseling, Placebo plus NRT plus counseling
PlaceboNormal saline.	Drug	Placebo plus NRT plus counseling

Primary outcome

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 6 weeks
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Time frame: 6 weeks
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
Time frame: 6 weeks
The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal.
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Time frame: 1 week
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Time frame: 3 weeks
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.

4 secondary outcomes

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 7 weeks (1 week after end of treatment)
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 10 weeks (4 weeks after end of treatment)
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Time frame: 7 weeks (1 week after end of treatment)
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Time frame: 10 weeks (4 weeks after end of treatment)

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide Plus NRT Plus Counseling	41	34
Placebo Plus NRT Plus Counseling	41	35

Primary outcome: Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Exenatide Plus NRT Plus Counseling n = 41	Placebo Plus NRT Plus Counseling n = 41
Value	19	11

Primary outcome: Post-quit Craving as Assessed by the Questionnaire of Smoking Urges

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Exenatide Plus NRT Plus Counseling n = 34	Placebo Plus NRT Plus Counseling n = 35
Value	17.2 (11.0)	16.9 (9.75)

Population analysed: Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit.

Primary outcome: Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Exenatide Plus NRT Plus Counseling n = 34	Placebo Plus NRT Plus Counseling n = 35
Value	40.5 (18.3)	44.5 (18.0)

Primary outcome: Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges

Time frame: 1 week

Population analysed: Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide Plus NRT Plus Counseling	0 of 41 (0%)	4 of 41 (9.8%)	0 of 41
Placebo Plus NRT Plus Counseling	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29480848Yammine L, Kosten TR, Cinciripini PM, Green CE, Meininger JC, Minnix JA, Newton TF. Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial. Medicine (Baltimore). 2018 Jan;97(2):e9567. doi: 10.1097/MD.0000000000009567.
Derived from this study: PubMed 33831213Yammine L, Green CE, Kosten TR, de Dios C, Suchting R, Lane SD, Verrico CD, Schmitz JM. Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2021 Aug 29;23(10):1682-1690. doi: 10.1093/ntr/ntab066.
Individual participant dataSharing planned: No

Related trials for Smoking Cessation

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
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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. This study is not recruiting at the moment.

Luba Yammine, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Exenatide, NRT and Counseling in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 28 Jan 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975297, which also lists 2 linked publications.

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 28 Jan 2021.