A randomized controlled trial to evaluate the efficacy of VARENICLINA to stop smoking in smokers of elettronic sigarette or in smokers who smoke both elettronic sigarette and classic sigarettes (VAREVAPE)

Phase 1

• Conditions: problems related to the use of nicotine; MedDRA version: 21.1Level: LLTClassification code 10068678Term: Nicotine abuseSystem Organ Class: 100000004873; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2016-000339-42-IT
• Lead Sponsor: CENTRO PER LA PREVENZIONE E CURA DEL TABAGISMO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

The study will enroll 140 Smokers of Electronic Cigarette (single users), from at least three months, who use liquid with nicotine and 140 smokers who combined use of electronic cigarette with nicotine and cigarette classic (dual users), from at least 3 months. Smokers willing to stop smoking, will be invited to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

It will be excluded patients with psychiatric illnesses and women who are pregnant and breastfeeding women. Patients with severe renal impairment and symptomatic vascular disease (including a history of ischemic heart disease, stroke) are also excluded from the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study intends to evaluate the efficacy and safety of varenicline 1 mg BID in the cessation of smoking electronic cigarette (single users) or combined use, electronic and classical cigarette (dual users).;Secondary Objective: Safety, predictors of abstinence at the end of the study, the percentage of study participants retention.;Primary end point(s): % of success in the Varenicline vs Placebo Group;Timepoint(s) of evaluation of this end point: at week 24th

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety, predictors of abstinence at the end of the study, % of intention of the study participants;Timepoint(s) of evaluation of this end point: Safety at each clinic visit<br>Predictors of abstinence at the end of the study and % of intention of the study participants at week 24th