Trial Outcomes & Findings for Trial on the Effectiveness of Mindfulness Training for Smokers (NCT NCT01093599)

Results Overview

Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

196 participants

Primary outcome timeframe

6 months post quit day

Results posted on

2015-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Quit Line Only Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.	Quit Line Plus MTS Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention. Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
Overall Study STARTED	91	105
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	32	46

Reasons for withdrawal

Reasons for withdrawal
Measure	Quit Line Only Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.	Quit Line Plus MTS Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention. Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
Overall Study Lost to Follow-up	32	46

Baseline Characteristics

Trial on the Effectiveness of Mindfulness Training for Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quit Line Only n=91 Participants Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.	Quit Line Plus MTS n=105 Participants Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention. Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention.	Total n=196 Participants Total of all reporting groups
Age, Continuous	40.95 years STANDARD_DEVIATION 12.05 • n=5 Participants	42.25 years STANDARD_DEVIATION 14.53 • n=7 Participants	41.65 years STANDARD_DEVIATION 13.92 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	53 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	52 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	105 participants n=7 Participants	196 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post quit day

Population: intent to treat analysis

Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.

Outcome measures

Outcome measures
Measure	Quit Line Only n=91 Participants Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.	Quit Line Plus MTS n=105 Participants Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention. Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
Smoking Abstinence	13 participants	24 participants

SECONDARY outcome

Timeframe: 6 months post quit day

Outcome measures

Outcome data not reported

Adverse Events

Quit Line Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Quit Line Plus MTS

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