Novel Psychosocial Influences on Smoking Cessation | NCT02173938

Studies
Novel Psychosocial Influences on Smoking Cessation

NCT02173938

Sponsor

Rutgers, The State University of New Jersey

Status

Completed

Last Update Posted

May 4, 2015Estimated

Enrollment

61Actual

Phase

Not provided

Conditions

Smoking

Interventions

Tobacco Dependence Treatment

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

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jun 23, 2014

First Submission Date that Met QC Criteria

Jun 24, 2014

First Posted Date

Jun 25, 2014Estimated

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

May 1, 2015

Last Update Posted Date

May 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael B. Steinberg, MD, MPH, FACP, Associate Professor of Medicine, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Our overall research goal is to determine how these novel psychosocial factors impact cessation. This pilot study will answer how dual use of other tobacco products, direct to consumer marketing, and the new phenomenon of butting-out and relighting influences cessation, and how understanding impulsivity and task persistence could lead to new and improved behavioral interventions for tobacco dependence. Answers to these pilot questions will lead to the publication of several manuscripts and provide important feasibility data to design large, well-powered clinical trials, population-level epidemiological studies, and contribute to furthering the field of tobacco treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment seekers			Other: Tobacco Dependence Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tobacco Dependence Treatment	Other	face to face, outpatient tobacco dependence treatment based on the Public Health Service guidelines for treating tobacco use and dependence	Treatment seekers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who have quit smoking		6 months post quit date

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

smokers 18 years of age or older

Exclusion Criteria:

non-English speaking participants

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult smokers 18 years and older seeking treatment for quitting smoking

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tobacco Dependence Program, Rutgers University		New Brunswick	New Jersey	08901	United States