Exenatide Once Weekly for Smoking Cessation

NCT02975297 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: HSC-MS-17-0802CCTS Research Scholar Award
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Keywords

smoking; pre-diabetes; overweight; exenatide; Glucagon-like peptide-1 (GLP-1) agonists

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

  7 weeks (1 week after end of treatment)

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

  10 weeks (4 weeks after end of treatment)

Study Arms (2)

Exenatide plus NRT plus counseling

EXPERIMENTAL

Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling

Drug: Exenatide; Drug: NRT; Behavioral: Counseling

Placebo plus NRT plus counseling

PLACEBO COMPARATOR

Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling

Drug: NRT; Behavioral: Counseling; Drug: Placebo

Interventions

Exenatide DRUG

Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.

Also known as: Bydureon

Exenatide plus NRT plus counseling

NRT DRUG

Nicotine Patch (21mg) / 24 hours.

Also known as: Nicotine patch

Exenatide plus NRT plus counseling; Placebo plus NRT plus counseling

Counseling BEHAVIORAL

Brief individual behavioral smoking cessation counseling.

Also known as: Smoking cessation counseling

Exenatide plus NRT plus counseling; Placebo plus NRT plus counseling

Placebo DRUG

Normal saline.

Placebo plus NRT plus counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 29480848 BACKGROUND

• 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.

  PMID: 33831213 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking; Glucose Intolerance; Overweight

Interventions

Exenatide; Tobacco Use Cessation Devices; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Luba Yammine, PhD, APRN, FNP-C, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

Luba.Yammine@uth.tmc.edu

(713) 500-2005

Study Officials

• Luba Yammine, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 29, 2016
• Study Start: July 1, 2016
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)