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Completed

NCT Number: NCT01451814

Development of Positive Psychotherapy for Smoking Cessation

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Psychotherapy for smoking cessation

Behavioral

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

Drug

8 weeks of nicotine patch

Relaxation Training

Behavioral

Instructions in progressive muscle relaxation

Behavioral smoking cessation treatment

Behavioral

Counseling on techniques to manage triggers and avoid smoking

Primary outcomes

  1. 7-day Point Prevalence Smoking Abstinence at 8 Weeks

    Time frame: 8 weeks

    Biochemically verified abstinence from smoking over the past 7 days

  2. 7-day Point Prevalence Smoking Abstinence at 16 Weeks

    Time frame: 16 Weeks

    Biochemically verified abstinence from smoking over the past 7 days

  3. 7-day Point Prevalence Smoking Abstinence at 26 Weeks

    Time frame: 26 Weeks

    Biochemically verified abstinence from smoking over the past 7 days

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2011
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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