Daily Liraglutide for Nicotine Dependence

What Was Tested

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

This clinical research trial examines the effects of the GLP-1 receptor agonist liraglutide on smoking behavior, food intake, and weight gain.

In this double-blind, placebo-controlled, parallel arm pilot study, overweight and obese smokers (N=40; 20 female and 20 male) will be randomized to 32 weeks of liraglutide or placebo and undergo 8 sessions of smoking cessation behavioral counseling.

Outcomes are smoking abstinence and weight change.

It had two arms (groups): Smoking Cessation Counseling & Liraglutide (experimental) and Smoking Cessation Counseling & Placebo (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

A growing literature indicates that common neurobiological substrates mediate drug addiction and obesity.

Importantly, post-cessation weight gain (PCWG) can deter a quit attempt, precipitate smoking relapse, and contribute to health issues related to excess body weight.

Although there is substantial variability in the amount of weight gained, individuals who successfully quit smoking gain an average of 4.2 kg, with estimates ranging from 2.5 kg to 8.6 kg, at 6-month follow-up.

Recent evidence indicates that glucagon-like peptide-1 (GLP-1) regulates the rewarding effects of nicotine.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years of age or older who self-report smoking cigarettes (menthol and non-menthol) at least 10 times per day, on average, for the past 6 months. Interested in quitting smoking (defined as "intend to quit within one month"). Able to communicate (speak, read, and write) fluently in English. Capable of giving written informed consent before any study-related activities, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form. If current or past diagnosis of bipolar disorder, eligible if:.

The full record lists 12 inclusion and 29 exclusion criteria; among the exclusions: daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes; self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months; A positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, and/or ecstasy (MDMA).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-11-29 with completion listed for 2022-05-25.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date (time frame: Week 18). Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date (time frame: Week 32).

It also tracked 2 secondary outcomes, for example Body Weight at 12 Weeks Post-Target Quit Date and Body Weight at 26 Weeks Post-Target Quit Date.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 40 people.

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

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