Current partner codePEPTIDESDE
NCT03204396·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

256

Locations

1

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jul 2, 2017

  2. Study start

    Jun 26, 2017

  3. Primary completion

    Jul 30, 2022

  4. Study completion

    Aug 30, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Sep 13, 2022

Outcomes

What the study measures.

Primary outcomes

Point prevalence abstinence rate at week 12

Time frame · 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 outcomes

Change in Body weight

Time frame · 12 weeks

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria for the main study: * Age 18 to 75 years * Daily smokers who are willing to quit and exhibit one of the following criteria: ≥10 cigarettes per day or * At least moderate nicotine dependence defined by a Fagerstroem Score of ≥5 Points or * Tobacco associated disease * Treatment with varenicline (Champix®) Additional Inclusion Criteria for the "substudy fMRI": * Only patients aged 18-50 years are eligible Additional Inclusion Criteria for the "substudy Energy": * BMI of 18-30 kg/m2 Exclusion Criteria for the main study: * Pregnancy (incl. wish to become pregnant within next 3 months) or breast feeding * Pre-existing Treatment with GLP-1 agonists * History of pancreatitis * Severe renal insufficiency (estimated glomerular Filtration rate smaller than 30 ml/min/1.73 m2) * Instable psychiatric conditions * Anorexia nervosa Additional Exclusion Criteria for the "substudy fMRI": * Medical conditions that affect brain function (e.g. stroke, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, dementia, transient ischemic attack), * Current use of medications that alter brain function * Current illicit drug abuse including marijuana (alcohol ≤ 1 drink per day allowed) * Claustrophobia, cardiac pacemaker, electronic device or ferromagnetic metal foreign bodies

Study locations

1 registered sites.

Switzerland. Showing up to 24 locations stored in the fast local snapshot.

Universitätsspital Basel

Basel, Switzerland

Publications

Results and literature.

PMID 40037282Beck J, Hasenbohler F, Werlen L, Lengsfeld S, Meienberg A, Bathelt C, Vogt D, Christ-Crain M, Burkard T, Winzeler B. Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment. Eur J Prev Cardiol. 2025 Oct 10;32(14):1394-1402. doi: 10.1093/eurjpc/zwaf055.PMID 38371479Luthi H, Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Laager M, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. Effect of dulaglutide in promoting abstinence during smoking cessation: 12-month follow-up of a single-centre, randomised, double-blind, placebo-controlled, parallel group trial. EClinicalMedicine. 2024 Feb 9;68:102429. doi: 10.1016/j.eclinm.2024.102429. eCollection 2024 Feb.PMID 38264360Baur F, Atila C, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial. BMJ Nutr Prev Health. 2023 Dec;6(2):301-309. doi: 10.1136/bmjnph-2023-000781. Epub 2023 Dec 19.PMID 37991022Probst L, Monnerat S, Vogt DR, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Effects of dulaglutide on alcohol consumption during smoking cessation. JCI Insight. 2023 Nov 22;8(22):e170419. doi: 10.1172/jci.insight.170419.PMID 37081574Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Coynel D, Vogt DR, Hemkens LG, Speich B, Zanchi D, Erlanger TE, Christ-Crain M, Winzeler B. Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study. Trials. 2023 Apr 20;24(1):284. doi: 10.1186/s13063-023-07164-9.PMID 36874396Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. EClinicalMedicine. 2023 Feb 21;57:101865. doi: 10.1016/j.eclinm.2023.101865. eCollection 2023 Mar.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

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