Trial Outcomes & Findings for Development of Positive Psychotherapy for Smoking Cessation (NCT NCT01451814)

NCT ID: NCT01451814

Last Updated: 2015-03-18

Results Overview

Biochemically verified abstinence from smoking over the past 7 days

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2015-03-18

Participant Flow

Participant milestones

Measure	Positive Psychotherapy 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
Overall Study STARTED	35	31
Overall Study Attended a Session	35	31
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Positive Psychotherapy 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	5	4

Baseline Characteristics

Development of Positive Psychotherapy for Smoking Cessation

Baseline characteristics by cohort

Measure	Positive Psychotherapy n=35 Participants 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment n=31 Participants 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Total n=66 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 13.1 • n=5 Participants	44.5 years STANDARD_DEVIATION 13.8 • n=7 Participants	46.2 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	29 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	31 participants n=7 Participants	66 participants n=5 Participants
Fagstrom Test for Nicotine Dependence	5.6 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	5.4 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	5.5 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Biochemically verified abstinence from smoking over the past 7 days

Outcome measures

Measure	Positive Psychotherapy n=35 Participants 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment n=31 Participants 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
7-day Point Prevalence Smoking Abstinence at 8 Weeks	40.0 percentage of participants abstinent	25.8 percentage of participants abstinent

PRIMARY outcome

Timeframe: 16 Weeks

Biochemically verified abstinence from smoking over the past 7 days

Outcome measures

Measure	Positive Psychotherapy n=35 Participants 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment n=31 Participants 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
7-day Point Prevalence Smoking Abstinence at 16 Weeks	22.9 percentage of participants abstinent	6.5 percentage of participants abstinent

PRIMARY outcome

Timeframe: 26 Weeks

Biochemically verified abstinence from smoking over the past 7 days

Outcome measures

Measure	Positive Psychotherapy n=35 Participants 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment n=31 Participants 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
7-day Point Prevalence Smoking Abstinence at 26 Weeks	17.1 percentage of participants abstinent	6.5 percentage of participants abstinent

Adverse Events

Positive Psychotherapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Positive Psychotherapy n=35 participants at risk 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking	Standard Treatment n=31 participants at risk 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking
Respiratory, thoracic and mediastinal disorders Hospitalization	2.9% 1/35 • Number of events 1	0.00% 0/31

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Kahler

Brown University School of Public Health

Phone: 401 863-6651

Email: Christopher_Kahler@brown.edu

Results disclosure agreements

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