Exenatide Once Weekly for Smoking Cessation

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

Official Title
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Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Exenatide
* Drug: NRT
* Behavioral: Counseling
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, pre-diabetes, overweight, exenatide, Glucagon-like peptide-1 (GLP-1) agonists