At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial
In Brief
A Phase 2 clinical trial evaluating Dulaglutide and 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) for Glucagon-like Peptide-1 and 3 related conditions. Completed, enrolled 256 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.
Application of 0.5 ml normal saline (0.9% sodium chloride \[0.9% NaCl\]) once weekly for 12 weeks