Trial Outcomes & Findings for Group Therapy for Nicotine Dependence: Mindfulness and Smoking (NCT NCT00297479)

NCT ID: NCT00297479

Last Updated: 2020-06-16

Results Overview

Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 650 participants
• Primary outcome timeframe: 4 weeks post quit day (one week following the end of treatment)
• Results posted on: 2020-06-16

Participant Flow

Participants were recruited from the Houston metropolitan area via local print media. All data collected between January 2007 to February 2010.

Out of the 650 participants, 412 were on the formal clinical trial and 238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.

Participant milestones

Measure	Usual Care Group Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
Overall Study STARTED	103	155	154
Overall Study 4-Week Follow Up	78	132	128
Overall Study 26- Week Follow Up	66	101	103
Overall Study COMPLETED	66	101	103
Overall Study NOT COMPLETED	37	54	51

Reasons for withdrawal

Measure	Usual Care Group Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
Overall Study Lost to Follow-up	37	54	51

Baseline Characteristics

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Baseline characteristics by cohort

Measure	Usual Care Group (UC) n=103 Participants 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) n=155 Participants 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) n=154 Participants 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence	Total n=412 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	155 Participants n=7 Participants	154 Participants n=5 Participants	412 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	49 years STANDARD_DEVIATION 12.5 • n=5 Participants	48.8 years STANDARD_DEVIATION 11.9 • n=7 Participants	48.4 years STANDARD_DEVIATION 11.7 • n=5 Participants	48.7 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	84 Participants n=7 Participants	84 Participants n=5 Participants	226 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	71 Participants n=7 Participants	70 Participants n=5 Participants	186 Participants n=4 Participants
Region of Enrollment United States	103 participants n=5 Participants	155 participants n=7 Participants	154 participants n=5 Participants	412 participants n=4 Participants
Kentucky Inventory of Mindfulness Skills (KIMS)	31.9 KIMS Score STANDARD_DEVIATION 4.0 • n=5 Participants	31.9 KIMS Score STANDARD_DEVIATION 3.6 • n=7 Participants	32.0 KIMS Score STANDARD_DEVIATION 3.8 • n=5 Participants	32.0 KIMS Score STANDARD_DEVIATION 3.8 • n=4 Participants
Mindful Attention Awareness Scale (MAAS)	4.2 MAAS Score STANDARD_DEVIATION .9 • n=5 Participants	4.3 MAAS Score STANDARD_DEVIATION .9 • n=7 Participants	4.3 MAAS Score STANDARD_DEVIATION 1.0 • n=5 Participants	4.3 MAAS Score STANDARD_DEVIATION .9 • n=4 Participants
Nicotine Dependence - Cigarettes per day	19.3 Cigarettes per day STANDARD_DEVIATION 8.6 • n=5 Participants	19.9 Cigarettes per day STANDARD_DEVIATION 9.3 • n=7 Participants	20.3 Cigarettes per day STANDARD_DEVIATION 11.7 • n=5 Participants	19.9 Cigarettes per day STANDARD_DEVIATION 10.1 • n=4 Participants
Nicotine Dependence - Participants reported smoking their first cigarette with 5 minutes of walking	39 Participants n=5 Participants	61 Participants n=7 Participants	59 Participants n=5 Participants	159 Participants n=4 Participants
Demographics (Education) < High School	10 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants
Demographics (Education) High School/GED	25 Participants n=5 Participants	37 Participants n=7 Participants	39 Participants n=5 Participants	101 Participants n=4 Participants
Demographics (Education) Some College	52 Participants n=5 Participants	76 Participants n=7 Participants	67 Participants n=5 Participants	195 Participants n=4 Participants
Demographics (Education) 4-year College Degree	10 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants	55 Participants n=4 Participants
Demographics (Education) > 4-year College Degree	6 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Demographics (Household Income) < $30,000/year	61 Participants n=5 Participants	89 Participants n=7 Participants	87 Participants n=5 Participants	237 Participants n=4 Participants
Demographics (Household Income) > $30,000/year	42 Participants n=5 Participants	66 Participants n=7 Participants	67 Participants n=5 Participants	175 Participants n=4 Participants
Demographics (Spouse/Partner)	76 Participants n=5 Participants	103 Participants n=7 Participants	109 Participants n=5 Participants	288 Participants n=4 Participants
Demographics (History of Depression)	22 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	71 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks post quit day (one week following the end of treatment)

Population: Completers-only

Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

Outcome measures

Measure	Usual Care Group (UC) n=66 Participants 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) n=101 Participants 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) n=103 Participants 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Number of Participants With Smoking Abstinence	21 Participants	39 Participants	43 Participants

PRIMARY outcome

Timeframe: 26 weeks post quit day

Population: Completers Only

Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

Outcome measures

Measure	Usual Care Group (UC) n=66 Participants 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) n=101 Participants 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) n=103 Participants 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Smoking Abstinence	13 Participants	24 Participants	20 Participants

PRIMARY outcome

Timeframe: 4 weeks post quit day (one week following the end of treatment)

Population: Intent to treat

Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

Outcome measures

Measure	Usual Care Group (UC) n=103 Participants 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) n=155 Participants 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) n=154 Participants 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Smoking Abstinence	25 Participants	50 Participants	52 Participants

PRIMARY outcome

Timeframe: 26 weeks post quit day

Population: Intent to treat

Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

Outcome measures

Measure	Usual Care Group (UC) n=103 Participants 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline	Cognitive Behavioral Treatment (CBT) n=155 Participants 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline	Mindfulness-Based Treatment Group (MBAT) n=154 Participants 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Smoking Abstinence	12 Participants	24 Participants	53 Participants

Adverse Events

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mindfulness-Based Treatment Group (MBAT)

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

Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical

UT MD Anderson Cancer Center

Phone: 713-563-0020

Email: sgiordan@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place