A Phase 2 interventional study of Positive Psychotherapy for smoking cessation and Nicotine polacrilex in Smoking, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Brown University · Phase 2, Interventional, and Treatment
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.
Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Positive Psychotherapy for smoking cessation · Drug: Nicotine polacrilex · Behavioral: Behavioral smoking cessation 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
Drug: Nicotine polacrilex · Behavioral: Relaxation training · Behavioral: Behavioral smoking cessation treatment
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.
8 weeks of nicotine patch
Instructions in progressive muscle relaxation
Counseling on techniques to manage triggers and avoid smoking
7-day Point Prevalence Smoking Abstinence at 8 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 8 weeks
7-day Point Prevalence Smoking Abstinence at 16 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 16 Weeks
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 26 Weeks
| Milestone | Positive Psychotherapy | Standard Treatment |
|---|---|---|
| Started | 35 | 31 |
| Attended a session | 35 | 31 |
| Completed | 29 | 26 |
| Not completed | 6 | 5 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Lost to follow-up | 5 | 4 |
Biochemically verified abstinence from smoking over the past 7 days
| percentage of participants abstinent | Positive Psychotherapy | Standard Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 8 Weeks | 40.0 | 25.8 |
Biochemically verified abstinence from smoking over the past 7 days
| percentage of participants abstinent | Positive Psychotherapy | Standard Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 16 Weeks | 22.9 | 6.5 |
Biochemically verified abstinence from smoking over the past 7 days
| percentage of participants abstinent | Positive Psychotherapy | Standard Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 17.1 | 6.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positive Psychotherapy | — | 1/35 (2.9%) | 0/35 (0%) |
| Standard Treatment | — | 0/31 (0%) | 0/31 (0%) |
| Event | Positive Psychotherapy | Standard Treatment |
|---|---|---|
| HospitalizationRespiratory, thoracic and mediastinal disorders | 1/35 | 0/31 |
Participants fully eligible and attending the first session of counseling
| Age, Continuous(years) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| Mean | 47.4 ± 13.1 | 44.5 ± 13.8 | 46.2 ± 13.5 |
| Sex: Female, Male(Participants) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| Female | 19 | 14 | 33 |
| Male | 16 | 17 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 35 | 29 | 64 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 9 |
| White | 29 | 25 | 54 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| United States | 35 | 31 | 66 |
| Fagstrom Test for Nicotine Dependence(units on a scale) | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| Mean | 5.6 ± 2.4 | 5.4 ± 2.2 | 5.5 ± 2.3 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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