Clinical trial NCT02975297: Exenatide Once Weekly for Smoking Cessation
Official title: Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking Cessation
Keywords: smoking
pre-diabetes
overweight
exenatide
Glucagon-like peptide-1 (GLP-1) agonists
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
timeFrame: 6 weeks
measure: Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
timeFrame: 6 weeks
measure: Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
timeFrame: 6 weeks
measure: Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
timeFrame: 1 week
measure: Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
timeFrame: 7 weeks (1 week after end of treatment)
measure: Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
timeFrame: 10 weeks (4 weeks after end of treatment)
measure: Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
timeFrame: 7 weeks (1 week after end of treatment)
measure: Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
timeFrame: 10 weeks (4 weeks after end of treatment)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Luba Yammine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.