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

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ClinicalTrials.gov Identifier: NCT03204396
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Glucagon-like Peptide-1 Smoking Cessation Weight Change, Body Craving Drug: Dulaglutide Drug: 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
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
Official Title: Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks.
Drug: Dulaglutide
Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.
Other Name: Trulicity

Placebo Comparator: Placebo group
0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Point prevalence abstinence rate at week 24 and 52 [ Time Frame: 52 weeks ]
    Point prevalence abstinence rate at weeks 24 and 52 of dulaglutide treatment and SOC versus SOC alone, confirmed with end-expiratory exhaled carbon monoxide measurements of 10 ppm or less

  2. Prolonged abstinence rate at week 24 and 52 [ Time Frame: 52 weeks ]
  3. Smoking reduction at week 12, 24, and 52 [ Time Frame: 52 weeks ]
  4. Change of craving at week 4 and 12 relative to baseline [ Time Frame: 12 weeks ]
  5. Change of body weight in kg (and BMI [kg/m²]) at week 4, 8, 24, and 52 [ Time Frame: 52 weeks ]
  6. Change in haemoglobin A1c levels at week 12, 24, and 52 [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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®)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204396


Contacts
Contact: Bettina Winzeler, Dr. +41615565075 bettina.winzeler@usb.ch
Contact: Nica Jeanloz, Dr. +41613285523 nicaanna.jeanloz@usb.ch

Locations
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Bettina Winzeler, Dr.    +41615565075    bettina.winzeler@usb.ch   
Contact: Nica Jeanloz, Dr.    +41613285523    nicaanna.jeanloz@usb.ch   
Principal Investigator: Bettina Winzeler, Dr.         
Sub-Investigator: Thilo Burkard, Dr.         
Sub-Investigator: Meienberg Andrea, Dr.         
Sub-Investigator: Meienberg Fabian, Dr.         
Sub-Investigator: Jeanloz Nica, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Bettina Winzeler, Dr. University Hospital Basel, Endokrinology, diabetology, metabolism

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03204396     History of Changes
Other Study ID Numbers: 2017-00286
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Body Weight Changes
Body Weight
Signs and Symptoms
Glucagon
Glucagon-Like Peptide 1
Dulaglutide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins
Hypoglycemic Agents