Exenatide Once Weekly for Smoking Cessation

Phase 1

Completed

Conditions: Smoking Cessation

Interventions: Drug: Exenatide
Drug: NRT
Drug: Placebo
Behavioral: Counseling

Registration Number: NCT02975297

Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus NRT plus counseling	Placebo	Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide plus NRT plus counseling	NRT	Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide plus NRT plus counseling	Counseling	Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Placebo plus NRT plus counseling	NRT	Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Placebo plus NRT plus counseling	Counseling	Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide plus NRT plus counseling	Exenatide	Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm	6 weeks
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges	3 weeks	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.
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges	6 weeks	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.
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges	10 weeks (4 weeks after end of treatment)	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.
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)