Trial Outcomes & Findings for Coping Skills Treatment for Smoking Cessation (NCT NCT01061528)

NCT ID: NCT01061528

Last Updated: 2018-10-16

Results Overview

1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 116 participants
• Primary outcome timeframe: Six months
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Distress Tolerance Cessation Counseling One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.	Standard Smoking Cessation Counseling One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Overall Study STARTED	62	54
Overall Study COMPLETED	59	52
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coping Skills Treatment for Smoking Cessation

Baseline characteristics by cohort

Measure	New Smoking Cessation Counseling n=62 Participants * One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.	Standard Smoking Cessation Counseling n=54 Participants * One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.	Total n=116 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
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants	54 Participants n=7 Participants	116 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.97 years STANDARD_DEVIATION 11.45 • n=5 Participants	47.31 years STANDARD_DEVIATION 10.98 • n=7 Participants	46.06 years STANDARD_DEVIATION 11.23 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	54 participants n=7 Participants	116 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

1. Carbon monoxide of expired air

2. Salivary cotinine level of saliva

Outcome measures

Measure	Distress Tolerance Cessation Counseling n=62 Participants One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.	Standard Smoking Cessation Counseling n=54 Participants One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Number of Participants With Biochemically Verified Smoking Abstinence	11 Participants	12 Participants

Adverse Events

Distress Tolerance Cessation Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Smoking Cessation Counseling

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. Richard A. Brown

University of Texas at Austin

Phone: 512-471-8584

Email: brown2@utexas.edu

Results disclosure agreements

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