Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01679236
First received: August 31, 2012
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Nicotine Dependence
Alcohol Use
Interventions: Behavioral: Mindfulness Training for Smokers
Behavioral: Interactive Learning for Smokers

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mindfulness Training for Smokers

Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.

Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).

Interactive Learning for Smokers

Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.

Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).


Participant Flow:   Overall Study
    Mindfulness Training for Smokers     Interactive Learning for Smokers  
STARTED     30     25  
COMPLETED     15     10  
NOT COMPLETED     15     15  
Lost to Follow-up                 15                 15  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total randomized

Reporting Groups
  Description
Mindfulness Training for Smokers

Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.

Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).

Interactive Learning for Smokers

Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.

Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).

Total Total of all reporting groups

Baseline Measures
    Mindfulness Training for Smokers     Interactive Learning for Smokers     Total  
Number of Participants  
[units: participants]
  30     25     55  
Age  
[units: years]
Mean ± Standard Deviation
  21.7  ± 2.42     22.2  ± 2.68     21.93  ± 2.53  
Gender  
[units: participants]
     
Female     9     7     16  
Male     21     18     39  
Region of Enrollment  
[units: participants]
     
United States     30     25     55  



  Outcome Measures

1.  Primary:   Smoking Abstinence   [ Time Frame: 2 weeks post quit day ]

2.  Secondary:   Alcohol Use in Study Subjects vs Controls   [ Time Frame: 2 weeks post quit day ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Participants were not blinded to their respective treatment conditions.
  2. Attrition reduced power and generalizability.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James M. Davis MD, Assistant Professor, Duke University
Organization: University of Wisconsin
phone: 608-217-9405
e-mail: jjamesdavis@hotmail.com


No publications provided by University of Wisconsin, Madison

Publications automatically indexed to this study:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01679236     History of Changes
Other Study ID Numbers: H-2006-0279, P50DA019706-09
Study First Received: August 31, 2012
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board