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Nicotine DependenceSTAMPNCT01753141

Smoking Treatment and Anxiety Management Program

A study testing Cognitive Behavioral Therapy for smoking cessation and Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction. in people with Nicotine Dependence, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Nicotine Dependence
What is being tested?
Cognitive Behavioral Therapy for smoking cessation and Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
1 siteUnited States
Study dates
Jan 2008to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Anxiety and Behavioral Health Clinic

    Tallahassee, Florida, 32306

Other trials in United States

About this study

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.

Being tested
Cognitive Behavioral Therapy for smoking cessation, Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
Keywords
Cognitive Behavioral Therapy, Smoking Cessation
Medical subject headings
Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for smoking cessationBehavioural

  • Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.Behavioural

    Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.

Study groups in NCT01753141
Study groupRoleWhat they receive
ActiveExperimentalCognitive Behavioral Therapy for smoking cessation plus anxiety sensitivity reduction.
Receives: Behavioral: Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.
ControlActive comparatorCognitive Behavioral Therapy for smoking cessation.
Receives: Behavioral: Cognitive Behavioral Therapy for smoking cessation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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").

    Measured: up to 2 years

Secondary outcomes (1)

  1. Smoking Status

    Measured: week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2012 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01753141
Sponsor's protocol ID
R01MH076629-01A1
Acronym
STAMP
Status last verified
Sep 2013
First submitted
17 Dec 2012
Last updated
26 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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 Disord. 2012 Jan;26(1):173-81. doi: 10.1016/j.janxdis.2011.10.007. Epub 2011 Nov 6.

    PubMed 22119451

  • 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.

    PubMed 22766487

  • 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.

    PubMed 22154236

  • 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.

    PubMed 22370063

  • 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: 10.1080/10550887.2012.665695.

    PubMed 22540436

  • 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 2011 Dec 3.

    PubMed 22209026

  • 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.

  • 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.

    PubMed 21471305

  • Rogers AH, Bakhshaie J, Garey L, Piasecki TM, Gallagher MW, Schmidt NB, Zvolensky MJ. Individual differences in emotion dysregulation and trajectory of withdrawal symptoms during a quit attempt among treatment-seeking smokers. Behav Res Ther. 2019 Apr;115:4-11. doi: 10.1016/j.brat.2018.10.007. Epub 2018 Oct 19.

    PubMed 30384961

  • Zvolensky MJ, Garey L, Allan NP, Farris SG, Raines AM, Smits JAJ, Kauffman BY, Manning K, Schmidt NB. Effects of anxiety sensitivity reduction on smoking abstinence: An analysis from a panic prevention program. J Consult Clin Psychol. 2018 May;86(5):474-485. doi: 10.1037/ccp0000288.

    PubMed 29683703

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for smoking cessation and Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction. in people with Nicotine Dependence, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Sensitivity Index (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01753141, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.

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