Exenatide Once Weekly for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975297
• Other study ID #: HSC-MS-17-0802
• Secondary ID: CCTS Research Sc
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2016
• Est. completion date: January 3, 2020

Study information

• Verified date: January 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Exenatide
Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
• NRT
Nicotine Patch (21mg) / 24 hours.

Behavioral:
• Counseling
Brief individual behavioral smoking cessation counseling.

Drug:
• Placebo
Normal saline.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of = 5ppm		6 weeks
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)