Trial Outcomes & Findings for Pilot Study on Mindfulness for Tobacco and Alcohol in University Students (NCT NCT01679236)

Results Overview

Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

55 participants

Primary outcome timeframe

2 weeks post quit day

Results posted on

2014-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	30	25
Overall Study COMPLETED	15	10
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Lost to Follow-up	15	15

Baseline Characteristics

Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Training for Smokers n=30 Participants 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 n=25 Participants 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 n=55 Participants Total of all reporting groups
Age, Continuous	21.7 years STANDARD_DEVIATION 2.42 • n=5 Participants	22.2 years STANDARD_DEVIATION 2.68 • n=7 Participants	21.93 years STANDARD_DEVIATION 2.53 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	25 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks post quit day

Population: total enrolled

Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day

Outcome measures

Outcome measures
Measure	Mindfulness Training for Smokers n=30 Participants 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 n=25 Participants 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).
Smoking Abstinence	6 participants	1 participants

SECONDARY outcome

Timeframe: 2 weeks post quit day

Timeline follow back participant self-report of daily alcohol use.

Outcome measures

Outcome data not reported

Adverse Events

Mindfulness Training for Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interactive Learning for Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James M. Davis MD, Assistant Professor, Duke University

University of Wisconsin

Phone: 608-217-9405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place