Will receive "high-intensity" intervention, which is a combination of pharmacological (varenicline) and behavioural support, described later.

Encouraged to quit smoking via own doctor and is prescribed varenicline.

Chronic Obstructive Pulmonary Disease

Smoking Cessation

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Varenicline for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.
Group-sessions in 6 months:
Preparation phase: 5 sessions Day 1-14: 5 sessions Day 15-30: 5 sessions Day 31-60: 5 sessions Day 61-90: 5 sessions Day 90-180: 5 sessions c) Hotline and scheduled phone consultations:
A hotline is established which the high-intensity group can call.
Weekly calls to all patients in the project for 26 weeks. Call for 5-10 min. If the patient has not had relapse, there will be called week 34 and week 42. If the patient has had relapse, calls continue until relapse-free for 10 weeks, then week 34 and week 42.
d) Buddy-arrangement: i. Patients who have completed the program and have become smoke-free, are matched with new ones in the program. A meeting frequency of approx. every 7-14 days. The first patients are matched with patients from pulmonary medical outpatient clinic who have ceased smoking.

High-intensity smoking cessation intervention

Varenicline prescribed for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.

Low-intensity smoking cessation intervention

World Health Organization. Chronic obstructive pulmonary disease fact sheet.

Danish Lung Association and www.lunge.dk. Key numbers on pulmonary diseases

Bispebjerg University Hospital

Hvidovre University Hospital

North Zealand Hospital

Department of Internal medicine, Herlev & Gentofte Universtity Hospital

TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol

A Randomized Open-label, Superiority, Multicenter, Two-arm Intervention Study of the Effect of "High-intensity" vs. 'Low-intensity' Smoking Cessation Intervention in Active Smokers With COPD

*Cotinine is analyzed in a urine sample, as validated point-prevalence for the last 7 days

Defined as cardiovascular death, acute myocardial infarction or unstable angina pectoris

Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Each item on the questionnaire is scored from 0-3. A person can score between 0 and 21 for either anxiety or depression. Higher scores indicate a more greater risk of either anxiety or depression.

These end-points are only examined on the first 50 who stop smoking from the "high-intensity" group against the first 50 who do not stop smoking from the "low-intensity" group.

Lung cancer, urothelial cancer, pancreatic cancer, esophageal cancer, pharyngeal cancer, laryngeal cancer, tongue cancer, oral cancer, tonsil cancer

The scale ranges from 1-5, higher score indicate a greater extent to which patients' breathlessness affects their mobility. Patients who score 3, 4 or 5 on MRC-dyspnea scale may be offered rehabilitation according to international recommendations.

Admission to psychiatry with depression as primary diagnosis
New start of antidepressant treatment after baseline
Clinically relevant changes in HADS score over 36 months
Changes in status from HAM-D score from baseline over 36 months

Pradeesh Sivapalan

MD, PhD student

This study will be performed as a randomized, open label, superiority, 2-arm intervention study in active smokers with COPD. A total of 600 participants will be included with startup 1st January 2020 and is expected to be completed 3 years later, January 2023. Participants are randomized (random allocation) 1:1 to a "low-intensity group" and a "high-intensity group". Stratified for age (>65 years vs. ≤65 years) and number of daily cigarettes (>10/day vs. ≤10/day). Blocked randomization through REDCap with blocks of varying sizes (4-8), which will not be disclosed. Participants, their data and laboratory specimens etc. will be assigned a coded identification number (ID) to maintain participant confidentiality.
Participants will be randomized to either a low-intensity or a high-intensity smoking cessation intervention.

Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.
Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.
Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Smokers were assigned to electronic cigarettes containing 18mg/mL of nicotine in either a tobacco flavor solution or a tobacco and menthol flavor solution and then switched to other flavor for an additional 7 to 10 days. Monitoring sessions occurred on the last day of trial period of each flavor.

Nicotine With Tobacco Flavor and With Tobacco & Menthol Flavor

Sex: Female, Male

To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.

Subjects received tobacco flavored nicotine for 7-10 days

Tobacco Flavor

Subjects received tobacco & menthol flavored nicotine for 7-10 days

Tobacco & Menthol Flavor

Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use

Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine

Tobacco Flavor/ Tobacco & Menthol Flavor

Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)

Tobacco & Menthol Flavor/Tobacco Flavor

First 7-10 Days

Second 7-10 Days

Dr. Cheryl Oncken

AE occurred in intervention "Tobacco Flavor Session 17-10 days"
Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)

Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor)

AE occurred in intervention "Tobacco Flavor Session 27-10 days"
Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)

Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor)

AE occurred in intervention "Tobacco & Menthol Flavor Session 17-10 days"
Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)

Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor)

AE occurred in intervention "Tobacco Flavor Session 2 7-10 days"
Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.
Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)

Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor)

Health Behavior

Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Nicotine concentrations with electronic cigarette use: effects of sex and flavor

cotinine/infarction

TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol

Effects of Electronic Cigarettes on Nicotine Concentrations

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