Overview

This trial is active, not recruiting.

Condition smoking
Treatment behavior smoking cessation counseling with nicotine patch
Phase phase 2
Sponsor Brown University
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date June 2015
Trial size 80 participants
Trial identifier NCT01451814, NCI-156241-1

Summary

The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
behavior smoking cessation counseling with nicotine patch
6 sessions of individual behavioral smoking cessation counseling that includes 8 weeks of transdermal nicotine patch.
(Active Comparator)
6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch.
behavior smoking cessation counseling with nicotine patch
6 sessions of individual behavioral smoking cessation counseling that includes 8 weeks of transdermal nicotine patch.

Primary Outcomes

Measure
7-day point prevalence smoking abstinence
time frame: 8 weeks
7-day point prevalence smoking abstinence
time frame: 16 weeks
7-day point prevalence smoking abstinence
time frame: 26 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use - willing to use the transdermal nicotine patch - report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking. Exclusion Criteria: - are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence) - taking prescribed psychotropic medication or receiving other forms of psychotherapy - concomitantly using other pharmacotherapies for smoking cessation - have any contraindications for use of the transdermal nicotine patch.

Additional Information

Official title Development of Positive Psychotherapy for Smoking Cessation
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Brown University.