Electronic Cigarettes or Nicotine Inhaler for Smoking Ces... | NCT02004171

Studies
Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

NCT02004171

Sponsor

New York State Psychiatric Institute

Status

Withdrawn

Last Update Posted

Oct 19, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Tobacco Use Disorder

Interventions

electronic cigarette
nicotine inhaler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50DA009236-20	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled. Changed requirements for studying e-cigarettes.

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 25, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2016

Last Update Posted Date

Oct 19, 2016Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Cigarette smoking remains the leading cause of preventable death and disease worldwide.

The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
electronic cigarette	Other	V2 Cigs with 24 mg nicotine cartridges	electronic cigarette

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cigarettes smoked over 24 hours		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Symptoms of nicotine withdrawal	We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.	4 weeks
Benefits from smoking cessation

Other Outcomes

Measure	Description	Time Frame
Body mass index	We will measure if body mass increases as a consequence of smoking cessation.	4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-60 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barney Vaughan, MD	New York State Psychiatric Institute/Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Substance Treatment and Research Services (STARS)		New York	New York	10032	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder
D000072137	Vaping
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D012907	Smoking

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D066300	Electronic Nicotine Delivery Systems
D009538	Nicotine

Ancestor Terms

ID	Term
D000074602	Smoking Devices
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture
D012991	Solanaceous Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided