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

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT03204396
Phase
PHASE2
Status
Completed

Conditions

  • Craving
  • Glucagon-like Peptide-1
  • Smoking Cessation
  • Weight Change, Body

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dulaglutide — DRUG
    Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.
  • 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) — DRUG
    Application of 0.5 ml normal saline (0.9% sodium chloride \[0.9% NaCl\]) once weekly for 12 weeks

Study Details

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.

Key Dates

Start date
Jun 26, 2017
Status verified
Sep 2022
Primary completion
Jul 30, 2022
Completion
Aug 30, 2022

Study Design

Enrollment
256 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Point prevalence abstinence rate at week 12 [ Time Frame: 12 weeks ]

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