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Development of Positive Psychotherapy for Smoking Cessation

This study is currently recruiting participants.
Verified October 2012 by Brown University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier:
NCT01451814
First received: October 11, 2011
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking
 Behavioral: Behavior smoking cessation counseling with nicotine patch
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Positive Psychotherapy for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brown University:

Primary Outcome Measures:
  • 7-day point prevalence smoking abstinence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Biochemically verified abstinence from smoking over the past 7 days

  • 7-day point prevalence smoking abstinence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Biochemically verified smoking abstinence over the past 7 days

  • 7-day point prevalence smoking abstinence [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Biochemically verified abstinence from smoking over the past 7 days


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: Behavior smoking cessation counseling with nicotine patch
6 sessions of individual behavioral smoking cessation counseling that includes 8 weeks of transdermal nicotine patch.
Active Comparator: Standard treatment
6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch.
 Behavioral: Behavior smoking cessation counseling with nicotine patch
6 sessions of individual behavioral smoking cessation counseling that includes 8 weeks of transdermal nicotine patch.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451814

Contacts
Contact: Chris Kahler, PhD Christopher_Kahler@brown.edu

Locations
United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Chris Kahler, PhD         Christopher_Kahler@brown.edu    
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
  More Information

No publications provided

Responsible Party: Christopher W. Kahler, Professor of Behavioral and Social Sciences, Brown University
ClinicalTrials.gov Identifier: NCT01451814     History of Changes
Other Study ID Numbers: NCI-156241-1
Study First Received: October 11, 2011
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
smoking cessation

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013