NCT02004171

Brief Summary

Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 19, 2016

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

November 25, 2013

Last Update Submit

October 17, 2016

Conditions

Tobacco Use Disorder

Keywords

electronic cigarettenicotine inhalersmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Cigarettes smoked over 24 hours

    4 weeks

Secondary Outcomes (3)

  • Symptoms of nicotine withdrawal

    4 weeks

  • Benefits from smoking cessation

    4 weeks

  • Adverse reaction to nicotine inhaler or electronic cigarette

    4 weeks

Other Outcomes (1)

  • Body mass index

    4 weeks

Study Arms (2)

electronic cigarette

EXPERIMENTAL

electronic cigarette 24mg cartridges; 1-2 cartridges daily

Other: electronic cigarette

nicotine inhaler

ACTIVE COMPARATOR

nicotine inhaler 10mg cartridge; max 16 cartridges daily

Drug: nicotine inhaler

Interventions

electronic cigaretteOTHER

V2 Cigs with 24 mg nicotine cartridges

electronic cigarette
nicotine inhalerDRUG

nicotine inhaler with 10 mg nicotine cartridges

Also known as: Nicotrol inhaler
nicotine inhaler

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old
  • Meet DSM-IV criteria for nicotine dependence
  • Seeking treatment for smoking cessation
  • Smoking at least 15 cigarettes per day
  • Capable of giving informed consent and complying with study procedures

You may not qualify if:

  • Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
  • Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study
  • Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
  • Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
  • Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
  • Current DSM-IV diagnosis of substance dependence, other than nicotine
  • Use of cannabis or alcohol on more than 20 days in the past 30 days
  • Risk for suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Treatment and Research Services (STARS)

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderVapingSmoking Cessation

Interventions

Electronic Nicotine Delivery SystemsNicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Barney Vaughan, MD

    New York State Psychiatric Institute/Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 9, 2013

Study Start

December 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 19, 2016

Record last verified: 2014-11

Locations

US(1)