Skip to main content
OpenTrials
Completed

NCT Number: NCT03603340

The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Depression

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Depression outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.

Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Smoking and depression are strongly associated. Individuals with depression are twice as likely to be smokers than persons without a depression. Studies have shown that attempts to quit tobacco smoking are more likely to fail for individuals with depression than without. Depressive symptoms are common in prolonged nicotine withdrawal and individuals with depression are more nicotine dependent and more likely to suffer depressive symptoms during nicotine withdrawal compared to smokers in the general population.

Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. ENDS with nicotine containing e-liquids may be effective in assisting with tobacco smoking cessation without suffering depressive symptoms.

This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes such as depression and exposure to inhaled chemicals.

For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Presence and severity of depression will be assessed using the 9-question depression scale from the patient health questionnaire (PHQ-9) at baseline and at 6, 12 and 24 months' follow-up.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Behavioral Symptoms Depression Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne, Lausanne, Canton of Vaud, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent as documented by signature
  • Persons aged 18 or older
  • Currently smoking 5 or more cigarettes a day for at least 12 months
  • Willing to try to quit smoking within the next 3 months,
  • Persons providing a valid phone number, a valid email address and/or a valid postal address.

Exclusion criteria

  • Known hypersensitivity or allergy to contents of the e-liquid
  • Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
  • Persons having used ENDS or tobacco heating systems regularly in the 3 months preceding the baseline visit
  • Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
  • Persons who cannot attend the 6- month follow-up visit for any reason
  • Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures

Treatment and study plan

ENDS (vaporizer/e-cig) and smoking cessation counseling

Other

Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Smoking cessation counseling

Other

Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Primary outcomes

  1. Assessment of severity of self-reported symptoms of depression_1

    Time frame: 6 months post quit date

    Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

  2. Assessment of severity of self-reported symptoms of depression_2

    Time frame: 12 months post quit date

    Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

  3. Assessment of severity of self-reported symptoms of depression_3

    Time frame: 24 months post quit date

    Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

Secondary outcomes

  1. Assessment of change of severity of self-reported symptoms of depression

    Time frame: Change from baseline to 6,12, 24 months post quit date

    Measured using the 9-question depression scale from the patient health questionnaire (PHQ-9). The PHQ-9 is it is used to monitor the severity of depression. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Federal Office of Public Health, Switzerland
  • Krebsforschung Schweiz, Bern, Switzerland
  • State Hospital, St. Gallen
  • Swiss National Science Foundation
  • University of Geneva, Switzerland
  • University of Lausanne
  • University of Zurich

Registry information

Official study title

Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Depression Substudy of ESTxENDS

Acronym: ESTxENDS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2018
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.