NCT02398487

Brief Summary

This is a pilot study to compare efficiency and tolerability of a personal vaporizers (PV) new generation electronic cigarette loaded with nicotine e-liquid with cigalike new generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of well characterized regular smokers unwilling to quit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

June 9, 2014

Last Update Submit

December 1, 2015

Conditions

Cigarette Addiction

Outcome Measures

Primary Outcomes (1)

  • Smoking Reduction

    50% reduction of cigarette smoked compared to baseline

    24 week

Secondary Outcomes (1)

  • Smoking Cessation

    24 week

Study Arms (3)

Personal Vaporizer

ACTIVE COMPARATOR

Personal Vaporizer loaded with nicotine

Device: Personal Vaporizer with nicotine

Cigalike

ACTIVE COMPARATOR

Cigalike loaded with nicotine

Device: cigalike with nicotine

Usual smoking

NO INTERVENTION

Interventions

cigalike with nicotineDEVICE

cigalike 24 mg nicotine or 16 mg nicotine

Cigalike
Personal Vaporizer with nicotineDEVICE

Personal Vaporizer 16 mg nicotine or 9 mg nicotine

Personal Vaporizer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in good general health
  • committed to follow the trial procedures

You may not qualify if:

  • recent vaping history (stopped vaping less than 3 months ago)
  • use of any other form of non combustible nicotine containing products (chewable tobacco or nicotine replacement therapy) symptomatic cardiovascular disease
  • clinical history of asthma and chronic obstructive pulmonary disease (COPD)
  • regular psychotropic medication use
  • current or past history of alcohol abuse
  • use of smokeless tobacco or nicotine replacement therapy, and pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro per la Prevenzione e Cura del Tabagismo University of Catania

Catania, Catania, 95100, Italy

Location

MeSH Terms

Interventions

Tobacco Use Cessation DevicesNebulizers and Vaporizers

Intervention Hierarchy (Ancestors)

TherapeuticsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2014

First Posted

March 25, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

IT(1)