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

Not Applicable

Completed

• Conditions: Smoking Cessation; Depression
• Interventions: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling; Other: Smoking cessation counseling

• Registration Number: NCT03603340
• Lead Sponsor: University of Bern

Brief Summary

--\> 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	ENDS (vaporizer/e-cig) and smoking cessation counseling	-
Control group	Smoking cessation counseling	-

Primary Outcome Measures

Name	Time	Method
Assessment of severity of self-reported symptoms of depression_1	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).
Assessment of severity of self-reported symptoms of depression_2	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).
Assessment of severity of self-reported symptoms of depression_3	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 Outcome Measures

Name	Time	Method
Assessment of change of severity of self-reported symptoms of depression	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).

Trial Locations

Locations (5)

Département de médecine interne, Hôpitaux universitaires de Genève; 🇨🇭 Geneva, Switzerland

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland

University Clinic for General Internal Medicine, Bern University Hospital; 🇨🇭 Bern, Switzerland

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich; 🇨🇭 Zürich, Switzerland