Exenatide Once Weekly for Smoking Cessation

• Status: Completed
• Trial end date: 2020-01-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Baylor College of Medicine; Michael Debakey Veterans Affairs Medical Center
• Treatments: Exenatide; Nicotine

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.