Study Two on the Effectiveness of Mindfulness Training for Smokers (MTS2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Davis, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01299909
First received: February 17, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.


Condition Intervention Phase
Nicotine Dependence
Behavioral: Integrated Training for Smokers
Behavioral: Mindfulness Training for Smokers
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 24 weeks post quit day ] [ Designated as safety issue: No ]
    Point prevalent smoking abstinence is measured by Carbon Monoxide Breath Testing in MTS vs ITS subjects at 4 and 24 weeks post quit day.


Secondary Outcome Measures:
  • Changes in self reported measures in study subjects vs. controls [ Time Frame: Baseline, 4 and 24 weeks post quit day ] [ Designated as safety issue: No ]
    MTS Questions Nicotine Dependence, Smoking Dependence Motives, group bonding, instructor bonding, mindfulness, depression, anxiety, Quality of Life, Experiential Avoidance and Stress.


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindfulness Training for Smokers
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Behavioral: Mindfulness Training for Smokers
8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
Other Names:
  • Study Group
  • MTS
Active Comparator: Integrated Training for Smokers
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Behavioral: Integrated Training for Smokers
8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
Other Names:
  • Control Group
  • ITS

Detailed Description:

The MTS2 Study is funded for through a five-year K23 NIH training grant (appendix) awarded to Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is N=240 adult smokers randomized to study treatments. Based on prior recruitment numbers, it is expected that roughly 50% (120) will choose to be in an intensive intervention and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either MTS (n = 60) or ITS (n=60). MTS is a smoking cessation intervention that provides 8 mindfulness classes over a 6-week period. ITS will provide participants will access to the Freedom From Smoking Online Premium Program (at no cost) plus 8 smoking cessation classes over a 6-week period. Participants who choose to be in a non-intensive intervention (n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line. At the Orientation Meeting, participants who decide to enter the study will be allowed to choose whether they enter an intensive or the non-intensive intervention. Intensive intervention participants will attend an additional meeting called the Introductory Meeting where they are will undergo randomization into either the MTS or ITS. The Introductory Meeting will also provide instruction on the use of nicotine patches, smoking calendars and provide intervention materials. The study employs 3 study assessment visits. Study Visit 1 follows the Orientation Meeting, Study Visit 2 is 4-weeks post-quit, Study Visit 3 is 24-weeks post-quit. All participants will receive 2 weeks of free nicotine patches and $30 for attending each of the two post-quit study visits.

The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be three years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through flyers, television, newspaper and radio advertisements.

The principal hypothesis for the study is that MTS compared to ITS will show significantly higher point prevalent Carbon Monoxide confirmed smoking abstinence rates at 4 and 24 weeks post quit. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life and bio-physiological markers such as weight, breath holding and hair cortisol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years or over;
  • Participants must express "high" motivation to quit smoking
  • Participants must express willingness to attend "all" meetings for 2 months
  • Smoke 5 or more cigarettes per day

Exclusion Criteria:

  • Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
  • Self report of using chewing tobacco, snuff or cigars in the last week.
  • High score on Patient Health Questionnaire Depression Screening Tool for severe depression and suicidal intention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299909

Contacts
Contact: James M Davis, MD 608-217-9405 jd4@medicine.wisc.edu
Contact: David Fraser 608-262-8673 dlf@ctri.medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention Recruiting
Madison, Wisconsin, United States, 53711
Contact: David Fraser    608-265-4561    dlf@ctri.wisc.medicine.edu   
Principal Investigator: Tim Baker, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: James M Davis, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: James Davis, James McDowell Davis, MD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01299909     History of Changes
Other Study ID Numbers: H-2011-0087, 1K23DA022471-01A1
Study First Received: February 17, 2011
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Mindfulness Training for Smokers
Smoking
Smoking cessation
Addiction
behavioral intervention
Nicotine
Tobacco
Mindfulness
Meditation
MBSR
Mindfulness Based Stress Reduction
Mindfulness Based Cognitive Therapy
MBCT
Mindfulness Based Relapse Prevention
MBRP
Mindfulness Training
Behavioral Intervention
Nicotine Patch
Quit Line
Phone counseling
Freedom from Smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014