Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues
Condition: Glucagon-like Peptide-1; Smoking Cessation; Weight Change, Body; Craving
MeSH terms: Body Weight Changes
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Dulaglutide; 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Trulicity
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment