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Development of Positive Psychotherapy for Smoking Cessation

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Brown University

Status and phase

Completed
Phase 2

Conditions

Smoking

Treatments

Drug: Nicotine polacrilex
Behavioral: Behavioral smoking cessation treatment
Behavioral: Positive Psychotherapy for smoking cessation
Behavioral: Relaxation training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01451814
NCI-156241-1

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

Positive psychotherapy
Experimental group
Description:
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.
Treatment:
Behavioral: Behavioral smoking cessation treatment
Drug: Nicotine polacrilex
Behavioral: Positive Psychotherapy for smoking cessation
Standard treatment
Active Comparator group
Description:
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
Treatment:
Behavioral: Relaxation training
Behavioral: Behavioral smoking cessation treatment
Drug: Nicotine polacrilex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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