Smoking
Conditions
Keywords
smoking cessation
Brief 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.
Interventions
BEHAVIORALPositive 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.
8 weeks of nicotine patch
BEHAVIORALRelaxation training
Instructions in progressive muscle relaxation
BEHAVIORALBehavioral smoking cessation treatment
Counseling on techniques to manage triggers and avoid smoking
Sponsors
National Cancer Institute (NCI)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 8 Weeks | 8 weeks | Biochemically verified abstinence from smoking over the past 7 days |
| 7-day Point Prevalence Smoking Abstinence at 16 Weeks | 16 Weeks | Biochemically verified abstinence from smoking over the past 7 days |
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 26 Weeks | Biochemically verified abstinence from smoking over the past 7 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 31 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Positive Psychotherapy | Standard Treatment | Total |
|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 13.1 | 44.5 years STANDARD_DEVIATION 13.8 | 46.2 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 29 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fagstrom Test for Nicotine Dependence | 5.6 units on a scale STANDARD_DEVIATION 2.4 | 5.4 units on a scale STANDARD_DEVIATION 2.2 | 5.5 units on a scale STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 25 Participants | 54 Participants |
| Region of Enrollment United States | 35 participants | 31 participants | 66 participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 31 |
| serious Total, serious adverse events | 1 / 35 | 0 / 31 |
Outcome results
Primary
7-day Point Prevalence Smoking Abstinence at 16 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 16 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Psychotherapy | 7-day Point Prevalence Smoking Abstinence at 16 Weeks | 22.9 percentage of participants abstinent |
| Standard Treatment | 7-day Point Prevalence Smoking Abstinence at 16 Weeks | 6.5 percentage of participants abstinent |
p-value: 0.0695% CI: [0.84, 22.1]Chi-squared
Primary
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 26 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Psychotherapy | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 17.1 percentage of participants abstinent |
| Standard Treatment | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 6.5 percentage of participants abstinent |
p-value: 0.1895% CI: [0.56, 16.11]Chi-squared
Primary
7-day Point Prevalence Smoking Abstinence at 8 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Psychotherapy | 7-day Point Prevalence Smoking Abstinence at 8 Weeks | 40.0 percentage of participants abstinent |
| Standard Treatment | 7-day Point Prevalence Smoking Abstinence at 8 Weeks | 25.8 percentage of participants abstinent |
p-value: 0.2295% CI: [0.67, 5.48]Chi-squared