Meriter Mindfulness Training for Smokers Program and Study | NCT02143752

Studies
Meriter Mindfulness Training for Smokers Program and Study

NCT02143752

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Jun 18, 2023Actual

Enrollment

93Actual

Phase

Not provided

Conditions

Smoking

Interventions

Mindfulness
Quit Line

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
2012-001	Other Grant/Funding Number	Meriter Hospital

Status Module

Record Verification Date

Apr 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

Feb 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 17, 2013

First Submission Date that Met QC Criteria

May 17, 2014

First Posted Date

May 21, 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

Jun 15, 2023

Last Update Posted Date

Jun 18, 2023Actual

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

The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.

Detailed Description

MTS: Mindfulness Training for Smokers Intervention. This is the 7-week quit smoking intervention developed by the PI.

QL: Quit Line Intervention. This is a program starting at makes use of the Wisconsin Tobacco Quit Line.

Meriter Smoking Cessation Program: A program offering the MTS and QL interventions to smokers at Meriter Hospital and Clinics.

Meriter Smoking Cessation Study: This is a study comprised of 2 phone surveys and 1 study visit that tests participants in the MTS and QL intervention. Participants in the Meriter Smoking cessation program will have the opportunity to decide if they would like to be in the study.

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

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness		Smokers enter a Mindfulness Training for Smokers course	Behavioral: Mindfulness
Quit Line		Smokers attempt smoking cessation with the help of the Wisconsin Tobacco Quit Line	Behavioral: Quit Line

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness	Behavioral	Group behavioral intervention using mindfulness to help smokers quit smoking	Mindfulness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
biochemically confirmed post treatment smoking abstinence	Carbon monoxide levels are obtained 10 days post quit. CO under 7 = abstinence.	10 days post quit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

everyday smoker

Exclusion Criteria:

current alcohol or other drug addiction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study subjects will be drawn from the Meriter Smoking Cessation Program, which is made up of two interventions: the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James M Davis, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meriter Hospital and Medical Clinics		Madison	Wisconsin	53703	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24006963	Result	Davis JM, Mills DM, Stankevitz KA, Manley AR, Majeskie MR, Smith SS. Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers. BMC Complement Altern Med. 2013 Sep 3;13:215. doi: 10.1186/1472-6882-13-215.

ID	Term
D012907	Smoking
D016739	Behavior, Addictive

ID	Term
D001519	Behavior
D003192	Compulsive Behavior
D007175	Impulsive Behavior

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities