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

NCT03204396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2022-09-13

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Dulaglutide

Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.

DRUG

0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])

Application of 0.5 ml normal saline (0.9% sodium chloride \[0.9% NaCl\]) once weekly for 12 weeks

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Bettina Winzeler, Dr. · University Hospital Basel, Endokrinology, diabetology, metabolism

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2022-07-30
Completion
2022-08-30

Countries

  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204396 on ClinicalTrials.gov