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)

Efficacy of smoking cessation with varenicline for e-cigarettes users: a randomized controlled trial (VAREVAPE) - UniCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000339-42-IT

Enrollment

280

Registered

2020-11-04

Start date

2016-08-29

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

problems related to the use of nicotine MedDRA version: 21.1 Level: LLT Classification code 10068678 Term: Nicotine abuse System Organ Class: 100000004873

Interventions

Trade Name: CHAMPIX - 1.0 MG COMPRESSE RIVESTITE CON FILM -USO ORALE FLACONE HDPE 56 COMPRESSE Product Name: Champix (Vareniclina) Product Code: [NO7BA03] Pharmaceutical Form: Film-coated tablet INN o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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 Predictors of abstinence at the end of the study and % of intention of the study participants at week 24th	—

Countries

Italy

Contacts

Public ContactMedicina Interna

Centro per la prevenzione e cura tabagismo, AOU Policlinico Vittorio Emanuele- Università di Catania

cpctunict@gmail.com0953781537

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026