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Effects of Semaglutide on Nicotine Intake

Plain-language guide to NCT05530577: phase 2 randomized trial of Semaglutide, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05530577
Phase
phase 2
Status
completed
Start
2022-10-07
Completion (planned or actual)
2024-05-13
Participants
24 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Tobacco Use Disorder; Nicotine Addiction
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

Advancing new smoking cessation therapies, including those targeting novel biological mechanisms, is a critical public health priority.

It had two arms (groups): Semaglutide (experimental) and Sham/Placebo (sham comparator).

Participants will receive sham subcutaneous injections over 9 weeks.

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Smoking 5+ cigarettes per day (on average) over the past year, with no period of abstinence \> 90 days. Biochemical verification of smoking status, based on expired CO \> 8 at baseline. Willingness to take study medication and complete study procedures. Willingness to complete lab sessions involving cigarette smoking. Ability to communicate in English.

The full record lists 6 inclusion and 31 exclusion criteria; among the exclusions: regular use of electronic nicotine delivery systems (ends/vaping), cigars, chewing tobacco or snuff, based on at least weekly use in the past 30 days; past 30-day use of nicotine replacement therapies/products; current engagement in alcohol or smoking cessation treatments, or currently engaged in intentional efforts to quit cigarette use.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-10-07 with completion listed for 2024-05-13.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Nicotine Self-Administration (time frame: Baseline (Week 0) to post-medication (Week 8)). Change in Nicotine Reinstatement Duration (time frame: Baseline (Week 0) to post-medication (Week 8)).

It also tracked 1 secondary outcome, for example Change in Daily Cigarette Smoking.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.