CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Nicotine polacrilex +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01451814
NCT01451814Phase 2Completed

Development of Positive Psychotherapy for Smoking Cessation

Brown University·interventional·Posted Oct 14, 2011·Updated Mar 18, 2015

In Brief

A Phase 2 clinical trial evaluating Positive Psychotherapy for smoking cessation, Nicotine polacrilex, and 2 other interventions for Smoking. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.7 years ago

Interventions

Positive Psychotherapy for smoking cessationbehavioral

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 polacrilexdrug

8 weeks of nicotine patch

Relaxation trainingbehavioral

Instructions in progressive muscle relaxation

Behavioral smoking cessation treatmentbehavioral

Counseling on techniques to manage triggers and avoid smoking