Effects of Semaglutide on Nicotine Intake
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ClinicalTrials.gov Identifier: NCT05530577 |
Recruitment Status :
Recruiting
First Posted : September 7, 2022
Last Update Posted : November 15, 2023
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Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | August 26, 2022 | ||||||||||||||||||
First Posted Date ICMJE | September 7, 2022 | ||||||||||||||||||
Last Update Posted Date | November 15, 2023 | ||||||||||||||||||
Actual Study Start Date ICMJE | October 7, 2022 | ||||||||||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Change in Daily Cigarette Smoking [ Time Frame: baseline (Week 0) to study endpoint (Week 10) ] Number of cigarettes consumed per day during medication exposure
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Effects of Semaglutide on Nicotine Intake | ||||||||||||||||||
Official Title ICMJE | Effects of Semaglutide on Nicotine Intake and Smoking Lapse | ||||||||||||||||||
Brief Summary | Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those targeting novel biological mechanisms, is a critical public health priority. Accumulating evidence from preclinical studies suggests that glucagon-like peptide-1 (GLP-1) receptor agonists reduce intake and/or reinstatement of addictive drugs, including nicotine. However, translational work is necessary to establish whether GLP-1 receptor agonists alter aspects of nicotine response and smoking behavior in smokers. Human laboratory studies play a pivotal role in drug development by providing a time- and cost-efficient means of validating preclinical findings, also providing an ideal platform for studying mechanisms of medication effects. This is an experimental investigation to examine the effects of an approved GLP-1 receptor agonist on nicotine intake and reinstatement. Dependent smokers will be enrolled in a double-blind, parallel-arm trial with laboratory endpoints. Laboratory procedures will include a validated procedure for measuring smoking lapse/reinstatement after overnight abstinence. This study will provide initial laboratory evidence for the potential efficacy of GLP-1 receptor agonists as adjunctive treatments for smoking cessation. | ||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized parallel group design. Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
48 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | May 2024 | ||||||||||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT05530577 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 21-1548 R21DA047663-02 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of North Carolina, Chapel Hill | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | University of North Carolina, Chapel Hill | ||||||||||||||||||
Verification Date | November 2023 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |