Smoking Treatment and Anxiety Management Program

Nicotine Dependence Clinical Trial

— STAMP  

Official title:

Smoking Treatment and Anxiety Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753141
• Other study ID #: R01 MH076629-01A1
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: September 25, 2013
• Start date: January 2008
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Behavioral:
• Cognitive Behavioral Therapy for smoking cessation

• 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.

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Brandt CP, Johnson KA, Schmidt NB, Zvolensky MJ. Main and interactive effects of emotion dysregulation and breath-holding duration in relation to panic-relevant fear and expectancies about anxiety-related sensations among adult daily smokers. J Anxiety Di — View Citation

Buckner JD, Joiner TE Jr, Schmidt NB, Zvolensky MJ. Daily marijuana use and suicidality: the unique impact of social anxiety. Addict Behav. 2012 Apr;37(4):387-92. doi: 10.1016/j.addbeh.2011.11.019. Epub 2011 Nov 25. — View Citation

Buckner JD, Zvolensky MJ, Schmidt NB. Cannabis-related impairment and social anxiety: the roles of gender and cannabis use motives. Addict Behav. 2012 Nov;37(11):1294-7. doi: 10.1016/j.addbeh.2012.06.013. Epub 2012 Jun 22. — View Citation

Capron DW, Blumenthal H, Medley AN, Lewis S, Feldner MT, Zvolensky MJ, Schmidt NB. Anxiety sensitivity cognitive concerns predict suicidality among smokers. J Affect Disord. 2012 May;138(3):239-46. doi: 10.1016/j.jad.2012.01.048. Epub 2012 Feb 26. — View Citation

Funk, A. P., Zvolensky, M. J., & Schmidt, N. B. Homework compliance in a brief cognitive-behavioral and pharmacological intervention for smoking. Journal of Smoking Cessation (6): 99-111, 2011.

Johnson KA, Farris SG, Schmidt NB, Zvolensky MJ. Anxiety sensitivity and cognitive-based smoking processes: testing the mediating role of emotion dysregulation among treatment-seeking daily smokers. J Addict Dis. 2012;31(2):143-57. doi: 10.1080/10550887.2 — View Citation

Leventhal AM, Zvolensky MJ, Schmidt NB. Smoking-related correlates of depressive symptom dimensions in treatment-seeking smokers. Nicotine Tob Res. 2011 Aug;13(8):668-76. doi: 10.1093/ntr/ntr056. Epub 2011 Apr 6. — View Citation

Peasley-Miklus CE, McLeish AC, Schmidt NB, Zvolensky MJ. An examination of smoking outcome expectancies, smoking motives and trait worry in a sample of treatment-seeking smokers. Addict Behav. 2012 Apr;37(4):407-13. doi: 10.1016/j.addbeh.2011.11.037. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Sensitivity Index	The ASI is a 16-item self-report measure that assesses the fear of consequences of bodily sensations associated with anxiety. Items are rated on a five-point Likert-type scale ranging from 0 (very little) to 4 (very much) and a total score is computed by summing all items. The ASI is hierarchical in structure with one higher order factor (AS) and three subfactors (physical, cognitive, and social concerns). The physical concerns subscale includes items related to the fear of consequences or presence of specific physical sensations (e.g. "When I notice that my heart is beating rapidly, I worry that I might have a heart attack"). The cognitive concerns subscale includes items related to potential mental health implications of sensations (e.g. "When I cannot keep my mind on a task, I worry that I might be going crazy"). The social concerns subscale includes items related to the potential social consequences of physical sensations (e.g. "It is important to me not to appear nervous").	up to 2 years	No
Secondary	Smoking Status		week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up	No