Mindfulness Training for Smoking Cessation | NCT01144689

Studies
Mindfulness Training for Smoking Cessation

NCT01144689

Sponsor

Yale University

Status

Completed

Last Update Posted

Jul 7, 2016Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Cigarette Smoking
Tobacco Smoking
Nicotine Dependence
Smoking Cessation

Interventions

Mindfulness Training
Smoking Cessation Therapy

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

Jul 2016

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 2009

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

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

Jul 5, 2016

Last Update Posted Date

Jul 7, 2016Estimated

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

The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.

Detailed Description

Not provided

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness Training	Experimental		Behavioral: Mindfulness Training
Smoking Cessation Therapy	Active Comparator		Behavioral: Smoking Cessation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Training	Behavioral	8 sessions of behavioral treatment for smoking cessation	Mindfulness Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Between group differences in continuous abstinence		during treatment and 6, 12 and 18 weeks after treatment initiation

Secondary Outcomes

Measure	Description	Time Frame
Between group differences in perceived stress		6, 12 and 18 weeks after treatment initiation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between the ages of 18 and 60
Smoking 10 or more cigarettes per day
Fewer than 3 months of smoking abstinence in the past year
Motivated to stop smoking

Exclusion Criteria:

Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
Use of another investigational drug within 30 days
Any serious or unstable disease within 6 months
Meets criteria for substance dependence within the past year
Left handed (will be excluded from fMRI only)

Accepts Healthy Volunteers

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Healthcare System		West Haven	Connecticut	06516	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21723049	Result	Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
23265088

ID	Term
D000073865	Cigarette Smoking
D000073869	Tobacco Smoking
D014029	Tobacco Use Disorder
D016540	Smoking Cessation
D012907	Smoking

ID	Term
D001519	Behavior
D064424	Tobacco Use
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders