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Exenatide Once Weekly for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02975297
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Luba Yammine, 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Exenatide Drug: NRT Behavioral: Counseling Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide plus NRT plus counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT, Patch), smoking cessation counseling
Drug: Exenatide
Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
Other Name: Bydureon

Drug: NRT
Nicotine Patch (21mg) / 24 hours.
Other Name: Nicotine patch

Behavioral: Counseling
Brief individual behavioral smoking cessation counseling.
Other Name: Smoking cessation counseling

Placebo Comparator: plus NRT plus counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT, Patch), smoking cessation counseling
Drug: NRT
Nicotine Patch (21mg) / 24 hours.
Other Name: Nicotine patch

Behavioral: Counseling
Brief individual behavioral smoking cessation counseling.
Other Name: Smoking cessation counseling

Drug: Placebo
Normal saline.




Primary Outcome Measures :
  1. Abstinence as assessed by self-report [ Time Frame: 3 weeks ]
  2. Abstinence as assessed by self-report [ Time Frame: 4 weeks ]
  3. Abstinence as assessed by self-report [ Time Frame: 5 weeks ]
  4. Abstinence as assessed by self-report [ Time Frame: 6 weeks ]
  5. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 3 weeks ]
  6. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 4 weeks ]
  7. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 5 weeks ]
  8. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 6 weeks ]
  9. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 3 weeks ]
  10. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 4 weeks ]
  11. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 5 weeks ]
  12. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 6 weeks ]
  13. Withdrawal symptoms as assessed by the Wisconsin Smoking Withdrawal Scale [ Time Frame: 3 weeks ]
  14. Withdrawal symptoms as assessed by the Wisconsin Smoking Withdrawal Scale [ Time Frame: 4 weeks ]
  15. Withdrawal symptoms as assessed by the Wisconsin Smoking Withdrawal Scale [ Time Frame: 5 weeks ]
  16. Withdrawal symptoms as assessed by the Wisconsin Smoking Withdrawal Scale [ Time Frame: 6 weeks ]
  17. Cue-induced craving for cigarettes following virtual reality exposure as assessed by the Questionnaire of Smoking Urges [ Time Frame: 1 week ]
  18. Cue-induced craving for cigarettes following virtual reality exposure as assessed by the Questionnaire of Smoking Urges [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Abstinence as assessed by self-report [ Time Frame: 7 weeks ]
  2. Abstinence as assessed by self-report [ Time Frame: 10 weeks ]
  3. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 7 weeks ]
  4. Abstinence as assessed by expired carbon monoxide (CO) levels [ Time Frame: 10 weeks ]
  5. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 7 weeks ]
  6. Post-quit craving as assessed by the Questionnaire of Smoking Urges [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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: 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975297


Contacts
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Contact: Luba Yammine, PhD 832-776-3151 luba.yammine@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Luba Yammine, PhD    832-776-3151    luba.yammine@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Luba Yammine, PhD The University of Texas Health Science Center, Houston

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Responsible Party: Luba Yammine, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02975297     History of Changes
Other Study ID Numbers: HSC-MS-17-0802
CCTS Research Scholar Award ( Other Identifier: UTHealth )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Luba Yammine, The University of Texas Health Science Center, Houston:
smoking
pre-diabetes
overweight
exenatide
GLP-1 agonists
Additional relevant MeSH terms:
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Exenatide
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists