Text Size

Smoking Treatment and Anxiety Management Program (STAMP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Norman Schmidt, Florida State University
ClinicalTrials.gov Identifier:
NCT01753141
First received: December 17, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused on helping people manage their anxiety while quitting smoking. The study involves coming in to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50 for their full participation as well as receive 6 weeks of free nicotine replacement patches.


Condition Intervention
Nicotine Dependence
 Behavioral: Cognitive Behavioral Therapy for smoking cessation
Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Smoking Treatment and Anxiety Management Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Anxiety Sensitivity Index [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up


Secondary Outcome Measures:
  • Smoking Status [ Time Frame: week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: January 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Cognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.
 Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.
Active Comparator: Control
Cognitive Behavioral Therapy for smoking cessation.
 Behavioral: Cognitive Behavioral Therapy for smoking cessation

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anxiety Sensitivity Index greater than 15
  • Daily smoker for at least 1 year
  • Less than 45 years old
  • Currently smoke at least 8 cigarettes per day
  • Report a motivation to quit smoking

Exclusion Criteria:

  • History of panic disorder
  • Psychotropic medication use (if not stable for 3 months)
  • History of significant medical condition
  • Current use of smoking cessation pharmacology
  • Use of other tobacco products
  • Planning to move in the next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753141

Locations
United States, Florida
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
  More Information

No publications provided

Responsible Party: Norman Schmidt, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01753141     History of Changes
Other Study ID Numbers: R01 MH076629-01A1
Study First Received: December 17, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
Cognitive Behavioral Therapy
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on June 13, 2013