Development of Positive Psychotherapy for Smoking Cessation

Smoking Clinical Trial

Official title:

Development of Positive Psychotherapy for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451814
• Other study ID #: NCI-156241-1
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2011
• Last updated: March 6, 2015
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• 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.

Drug:
• Nicotine polacrilex
8 weeks of nicotine patch

Behavioral:
• Relaxation training
Instructions in progressive muscle relaxation
• Behavioral smoking cessation treatment
Counseling on techniques to manage triggers and avoid smoking

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies, Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence Smoking Abstinence at 8 Weeks	Biochemically verified abstinence from smoking over the past 7 days	8 weeks	No
Primary	7-day Point Prevalence Smoking Abstinence at 16 Weeks	Biochemically verified abstinence from smoking over the past 7 days	16 Weeks	No
Primary	7-day Point Prevalence Smoking Abstinence at 26 Weeks	Biochemically verified abstinence from smoking over the past 7 days	26 Weeks	No