Exenatide Once Weekly for Smoking Cessation
Purpose
The purpose of this study is to identify a potential new treatment for smoking cessation.
Condition
- Smoking Cessation
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Exenatide plus NRT plus counseling |
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
|
|
Placebo Comparator Placebo plus NRT plus counseling |
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston