Exenatide Once Weekly for Smoking Cessation

NCT ID: NCT02975297

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-01-03

Brief Summary

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

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Exenatide plus NRT plus counseling

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

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

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

NRT

Intervention Type: DRUG

Nicotine Patch (21mg) / 24 hours.

Counseling

Intervention Type: BEHAVIORAL

Brief individual behavioral smoking cessation counseling.

Placebo plus NRT plus counseling

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

Group Type: PLACEBO_COMPARATOR

NRT

Intervention Type: DRUG

Nicotine Patch (21mg) / 24 hours.

Counseling

Intervention Type: BEHAVIORAL

Brief individual behavioral smoking cessation counseling.

Placebo

Intervention Type: DRUG

Normal saline.

Interventions

Exenatide

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

Intervention Type: DRUG

NRT

Nicotine Patch (21mg) / 24 hours.

Intervention Type: DRUG

Counseling

Brief individual behavioral smoking cessation counseling.

Intervention Type: BEHAVIORAL

Placebo

Normal saline.

Intervention Type: DRUG

Other Intervention Names

Bydureon; Nicotine patch; Smoking cessation counseling

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Luba Yammine

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luba Yammine, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29480848 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33831213 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CCTS Research Scholar Award

Identifier Type: OTHER

Identifier Source: secondary_id

HSC-MS-17-0802

Identifier Type: -

Identifier Source: org_study_id