Exenatide Once Weekly for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Placebo; Drug: Exenatide; Drug: NRT; Behavioral: Counseling

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exenatide plus NRT plus counseling; Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling	Drug: Exenatide; Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.; Other Names: Bydureon; Drug: NRT; Nicotine Patch (21mg) / 24 hours.; Other Names: Nicotine patch; Behavioral: Counseling; Brief individual behavioral smoking cessation counseling.; Other Names: Smoking cessation counseling
PLACEBO_COMPARATOR: Placebo plus NRT plus counseling; Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling	Drug: Placebo; Normal saline.; Drug: NRT; Nicotine Patch (21mg) / 24 hours.; Other Names: Nicotine patch; Behavioral: Counseling; Brief individual behavioral smoking cessation counseling.; Other Names: Smoking cessation counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm		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.	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.	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.	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm		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		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.	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.	10 weeks (4 weeks after end of treatment)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): January 3, 2020
• Study Completion (ACTUAL): January 3, 2020

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (ESTIMATE): November 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: overweight; smoking; exenatide; pre-diabetes; Glucagon-like peptide-1 (GLP-1) agonists
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Anti-Obesity Agents; Incretins; Nicotine; Exenatide
• Other Study ID Numbers: HSC-MS-17-0802; CCTS Research Scholar Award (OTHER: UTHealth)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No