Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Exenatide Once Weekly for Smoking Cessation

NCTNCT02975297Other idHSC-MS-17-0802Other idCCTS Research Scholar Award

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 84 participants (actual)
Sponsor: The University of Texas Health Science Center, Houston · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Jul 2016
Primary completion: 3 Jan 2020
Completion: 3 Jan 2020
First posted: 29 Nov 2016 (estimated)
Last update posted: 28 Jan 2021
Conditions: Smoking Cessation

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018201920202021

Ph 1/2
Exenatide Once Weekly for Smoking Cessation
NCT02975297
Jul 2016 to 3 Jan 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

ExenatideDrug
NRTDrug
CounselingBehavioral
PlaceboDrug

Arms2

Experimental
Exenatide plus NRT plus counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Placebo comparator
Placebo plus NRT plus counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling

Primary outcomes5

Outcomes the sponsor listed as primary.

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
Registry description
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
Registry description
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
Registry description
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
Registry description
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.

Secondary outcomes(4)

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)
Registry description
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.
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Time frame · 10 weeks (4 weeks after end of treatment)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 6 weeks

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

Group	Value (Participants)
Exenatide Plus NRT Plus Counseling	19
Placebo Plus NRT Plus Counseling	11

Primary outcomeMean· 6 weeks

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

Group	Value (score on a scale)	Spread
Exenatide Plus NRT Plus Counseling	17.2	11.0
Placebo Plus NRT Plus Counseling	16.9	9.75

Primary outcomeMean· 6 weeks

Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale

Group	Value (score on a scale)	Spread
Exenatide Plus NRT Plus Counseling	40.5	18.3
Placebo Plus NRT Plus Counseling	44.5	18.0

Primary outcome· 1 week

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

Group	Value
Exenatide Plus NRT Plus Counseling	not posted
Placebo Plus NRT Plus Counseling	not posted

Primary outcome· 3 weeks

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

Group	Value
Exenatide Plus NRT Plus Counseling	not posted
Placebo Plus NRT Plus Counseling	not posted

Secondary and other outcome results(3)

Secondary outcomeCount of participants· 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

Group	Value (Participants)
Exenatide Plus NRT Plus Counseling	15
Placebo Plus NRT Plus Counseling	7

Secondary outcomeCount of participants· 10 weeks (4 weeks after end of treatment)

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

Group	Value (Participants)
Exenatide Plus NRT Plus Counseling	9
Placebo Plus NRT Plus Counseling	4

Secondary outcomeMean· 7 weeks (1 week after end of treatment)

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

Group	Value (score on a scale)	Spread
Exenatide Plus NRT Plus Counseling	13.3	7.86
Placebo Plus NRT Plus Counseling	14.2	8.47

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide Plus NRT Plus CounselingOnce weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks. NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling.	0 / 41	0 / 41	4 / 41
Placebo Plus NRT Plus CounselingOnce weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. Placebo: Normal saline.	0 / 41	0 / 41	1 / 41

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.

Yammine et al. 2021Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobaccocited by 100

PMID 33831213PMC8517504DOI 10.1093/ntr/ntab066PUB-33831213

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * 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); * 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.

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