Development of Positive Psychotherapy for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier:
NCT01451814
First received: October 11, 2011
Last updated: March 6, 2015
Last verified: March 2015
  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: Positive Psychotherapy for smoking cessation
Drug: Nicotine polacrilex
Behavioral: Relaxation training
Behavioral: Behavioral smoking cessation treatment
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:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • 7-day Point Prevalence Smoking Abstinence at 8 Weeks [ 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 at 16 Weeks [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Biochemically verified abstinence from smoking over the past 7 days

  • 7-day Point Prevalence Smoking Abstinence at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    Biochemically verified abstinence from smoking over the past 7 days


Enrollment: 66
Study Start Date: October 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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: 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: Behavioral smoking cessation treatment
Counseling on techniques to manage triggers and avoid smoking
Active Comparator: 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
Drug: Nicotine polacrilex
8 weeks of nicotine patch
Behavioral: Relaxation training
Instructions in progressive muscle relaxation
Behavioral: Behavioral smoking cessation treatment
Counseling on techniques to manage triggers and avoid smoking

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
  More Information

Publications:
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
Results First Received: February 23, 2015
Last Updated: March 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
smoking cessation

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

ClinicalTrials.gov processed this record on March 26, 2015