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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2022-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, placebo-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks.

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

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

Placebo group

0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe once weekly for 12 weeks.

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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Dulaglutide

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Trulicity

Eligibility Criteria

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Inclusion Criteria

* 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®)

* Only patients aged 18-50 years are eligible

* BMI of 18-30 kg/m2

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes