Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

Phase 2

Completed

• Conditions: Smoking Cessation; Weight Change, Body; Glucagon-like Peptide-1; Craving
• Interventions: Drug: 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]); Drug: Dulaglutide

• Registration Number: NCT03204396
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break whereby main reasons for not quitting or relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy intake and therefore body weight. Recent findings from animal and human studies suggest a role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in nicotine reward regulation combined with its weight reducing effects might be of major interest in view of novel pharmacotherapeutic options for smoking cessation.

* Substudy "fMRI": This substudy is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking.

* Substudy "Energy": This substudy is to investigate the effect of Dulaglutide (Trulicity®) on REE and further parameters associated with energy metabolism (bodycomposition, haemodynamic parameters and catecholamine action) in a subset of patients recruited for the main trial.

Detailed Description

Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break and despite established smoking cessation programs quit rates are low, especially in the real-life setting. The main reasons for not quitting or relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy intake and therefore body weight. Recent findings from animal and human studies suggest a role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in nicotine reward regulation combined with its weight reducing effects might be of major interest in view of novel pharmacotherapeutic options for smoking cessation.

* Substudy "fMRI" (60 patients): Supposing that GLP-1 and analogues modulates nicotine induces reward system this substudy is to analyze if treatment with Dulaglutide (Trulicity®) attenuates craving and therefore functional brain activation. It is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking.

* Substudy "Energy" (60 patients): The aim of the substudy "Energy" is to investigate the effect of Dulaglutide (Trulicity®) on REE and further parameters associated with energy metabolism (bodycomposition, haemodynamic parameters and catecholamine action) in a subset of patients recruited for the main trial.

Study Timeline

• Study Start: 2017-06-26
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])	0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe once weekly for 12 weeks.
Intervention group	Dulaglutide	Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Point prevalence abstinence rate at week 12	12 weeks	Point prevalence abstinence rate at week 12 of dulaglutide treatment and Standard of care (SOC) versus SOC alone, confirmed with end-expiratory exhaled carbon monoxide measurements of 10 ppm or less

Secondary Outcome Measures

Name	Time	Method
Change in Body weight	12 weeks	Change in body weight in kg (and BMI \[kg/m²\]) relative to baseline at week 12 of dulaglutide treatment versus placebo.

Trial Locations

Locations (1)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland