SmokingPhase 2NCT01451814

Development of Positive Psychotherapy for Smoking Cessation

A Phase 2 study testing Positive Psychotherapy for smoking cessation, Nicotine polacrilex and Relaxation training in people with Smoking, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Positive Psychotherapy for smoking cessation, Nicotine polacrilex and Relaxation training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Feb 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912

Other trials in United States

About this study

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.

Conditions: Smoking
Being tested: Positive Psychotherapy for smoking cessation, Nicotine polacrilex, Relaxation training, Behavioral smoking cessation treatment
Keywords: smoking cessation
Medical subject headings: Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Psychotherapy for smoking cessationBehavioural
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 trainingBehavioural
Instructions in progressive muscle relaxation
Behavioral smoking cessation treatmentBehavioural
Counseling on techniques to manage triggers and avoid smoking

Study groups in NCT01451814
Study group	Role	What they receive
Positive psychotherapy	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. Receives: Behavioral: Positive Psychotherapy for smoking cessation; Drug: Nicotine polacrilex; Behavioral: Behavioral smoking cessation treatment
Standard treatment	Active comparator	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 Receives: Drug: Nicotine polacrilex; Behavioral: Relaxation training; Behavioral: Behavioral smoking cessation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

7-day Point Prevalence Smoking Abstinence at 8 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Measured: 8 weeks
7-day Point Prevalence Smoking Abstinence at 16 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Measured: 16 Weeks
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Biochemically verified abstinence from smoking over the past 7 days
Measured: 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Feb 2014

First posted14 Oct 2011 (estimated)
Study startOct 2011
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Brown UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01451814
Sponsor's protocol ID: NCI-156241-1
Status last verified: Mar 2015
First submitted: 11 Oct 2011
Last updated: 18 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kahler CW, Spillane NS, Day AM, Cioe PA, Parks A, Leventhal AM, Brown RA. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2015 Nov;17(11):1385-92. doi: 10.1093/ntr/ntv011. Epub 2015 Feb 2.
PubMed 25646352

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Positive Psychotherapy for Smoking Cessation
ClinicalTrials.gov ID: NCT01451814
Acronym / sponsor ID: NCI-156241-1
Conditions: Smoking
Keywords: smoking cessation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Oct 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 14 Oct 2011 (estimated)
Results: Posted 18 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Positive psychotherapy	Experimental	Behavioral: Positive Psychotherapy for smoking cessation, Drug: Nicotine polacrilex, Behavioral: Behavioral smoking cessation treatment6 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.
Standard treatment	Active comparator	Drug: Nicotine polacrilex, Behavioral: Relaxation training, Behavioral: Behavioral smoking cessation treatment6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive Psychotherapy for smoking cessation6 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.	Behavioural	Positive psychotherapy
Nicotine polacrilex8 weeks of nicotine patch	Drug	Positive psychotherapy, Standard treatment
Relaxation trainingInstructions in progressive muscle relaxation	Behavioural	Standard treatment
Behavioral smoking cessation treatmentCounseling on techniques to manage triggers and avoid smoking	Behavioural	Positive psychotherapy, Standard treatment

Primary outcome

7-day Point Prevalence Smoking Abstinence at 8 Weeks
Time frame: 8 weeks
Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 16 Weeks
Time frame: 16 Weeks
Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Time frame: 26 Weeks
Biochemically verified abstinence from smoking over the past 7 days

Results and safety

Results posted to the registry on 18 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Positive Psychotherapy	35	29
Standard Treatment	31	26

Primary outcome: 7-day Point Prevalence Smoking Abstinence at 8 Weeks

Time frame: 8 weeks. Number. Unit: percentage of participants abstinent

Measure	Positive Psychotherapy n = 35	Standard Treatment n = 31
Value	40.0	25.8

Positive Psychotherapy vs Standard Treatment: Odds Ratio (OR): 1.91 (95% CI 0.67 to 5.48), p = .22, Chi-squared

Primary outcome: 7-day Point Prevalence Smoking Abstinence at 16 Weeks

Time frame: 16 Weeks. Number. Unit: percentage of participants abstinent

Measure	Positive Psychotherapy n = 35	Standard Treatment n = 31
Value	22.9	6.5

Positive Psychotherapy vs Standard Treatment: Odds Ratio (OR): 4.3 (95% CI 0.84 to 22.1), p = .06, Chi-squared

Primary outcome: 7-day Point Prevalence Smoking Abstinence at 26 Weeks

Time frame: 26 Weeks. Number. Unit: percentage of participants abstinent

Measure	Positive Psychotherapy n = 35	Standard Treatment n = 31
Value	17.1	6.5

Positive Psychotherapy vs Standard Treatment: Odds Ratio (OR): 3.0 (95% CI 0.56 to 16.11), p = .18, Chi-squared

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Positive Psychotherapy	1 of 35 (2.9%)	0 of 35 (0%)	Not reported
Standard Treatment	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25646352Kahler CW, Spillane NS, Day AM, Cioe PA, Parks A, Leventhal AM, Brown RA. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2015 Nov;17(11):1385-92. doi: 10.1093/ntr/ntv011. Epub 2015 Feb 2.

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Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Positive Psychotherapy for smoking cessation, Nicotine polacrilex and Relaxation training in people with Smoking, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Point Prevalence Smoking Abstinence at 8 Weeks (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01451814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.