AzTrials
AzTrials

Smoking CessationNCT00449293

Behavioral Therapy for Reduction in Smoking Craving

A study testing standard cognitive behavioral therapy and Mindfulness Based Cognitive Therapy in people with Smoking Cessation and Tobacco Dependence, run by University of Pittsburgh 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
Search all trials

Trial summary

The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Tobacco Dependence
What is being tested?
standard cognitive behavioral therapy and Mindfulness Based Cognitive Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2006to May 2008
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
  • Subjects must smoke at least 10 cigarettes per day
  • Must be at least 18 years old
  • English speaking
  • Able to read, understand, and complete a written questionnaire
  • Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
Show all 9Show fewer
  • Must not currently be using pharmacologic therapy to quit
  • Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
  • Only strongly right-handed subjects will be included

Who cannot join

  • Pregnant women
  • Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
  • Weigh over 300 pounds
  • Known problem of claustrophobia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.

Read the detailed description

The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.

Being tested
standard cognitive behavioral therapy, Mindfulness Based Cognitive Therapy
Keywords
Smoking cessation, Tobacco dependence, Mindfulness, fMRI, Craving
Medical subject headings
Smoking Cessation, Tobacco Use Disorder

What participants receive

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

  • standard cognitive behavioral therapyBehavioural

    Standard therapy to help participants with smoking cessation.

  • Mindfulness Based Cognitive TherapyBehavioural

    A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.

Study groups in NCT00449293
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Behavioral: standard cognitive behavioral therapy
2Active comparatorNot described
Receives: Behavioral: Mindfulness Based Cognitive Therapy

What is being measured

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

  1. Feasibility of recruitment and retention of participants

    Measured: baseline - session 8 and 6 month follow-up

  2. Participant acceptability of novel behavioral intervention (mindfulness)

    Measured: baseline - session 8

Secondary outcomes (17)

  1. Smoking cessation

    Measured: baseline - session 8 and 6 month follow-up

  2. Exhaled CO readings

    Measured: baseline, sessions 5 & 8

  3. Salivary cotinine measures

    Measured: baseline and sessions 5 & 8

  4. Psychological Measures

    Measured: baseline & session 8

  5. Craving response from a smoking cue (fMRI)

    Measured: Sessions 1,5, & 8

  6. Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)

    Measured: Sessions 1,5, & 8

  7. Self Reported Measures:

    Measured: baseline, sessions 5 & 8

  8. Trait Self-Control Scale

    Measured: baseline & session 8

  9. State Ego Depletion Scale

    Measured: baseline & session 8

  10. Self-Efficacy Scale

    Measured: baseline & session 8

  11. Perceived Stress Scale

    Measured: baseline & session 8

  12. Positive and Negative Affect Scale

    Measured: baseline & session 8

  13. Difficulties in Emotional Regulation Scale

    Measured: baseline & session 8

  14. Snaith-Hamilton Hedonic Capacity Scale

    Measured: baseline & session 8

  15. Mindful Attention Awareness Scale

    Measured: baseline & session 8

  16. Kentucky Inventory of Mindfulness Scales

    Measured: baseline & session 8

  17. Mindfulness meditation practice (mindfulness participants only, time in minutes

    Measured: sessions 1-8

Timeline

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

  1. First posted20 Mar 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2007
  4. Study completionMay 2008

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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00449293
Sponsor's protocol ID
0606054
Status last verified
Jan 2008
First submitted
16 Mar 2007
Last updated
31 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Astin JA, Shapiro SL, Eisenberg DM, Forys KL. Mind-body medicine: state of the science, implications for practice. J Am Board Fam Pract. 2003 Mar-Apr;16(2):131-47. doi: 10.3122/jabfm.16.2.131.

    PubMed 12665179

  • Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.

    PubMed 15358875

  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

    PubMed 12703651

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.

    PubMed 12883106

  • Gilbert DG, McClernon FJ, Rabinovich NE, Dibb WD, Plath LC, Hiyane S, Jensen RA, Meliska CJ, Estes SL, Gehlbach BA. EEG, physiology, and task-related mood fail to resolve across 31 days of smoking abstinence: relations to depressive traits, nicotine exposure, and dependence. Exp Clin Psychopharmacol. 1999 Nov;7(4):427-43. doi: 10.1037//1064-1297.7.4.427.

    PubMed 10609977

  • Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.

    PubMed 11020090

Questions about this trial

What is this clinical trial studying?

A study testing standard cognitive behavioral therapy and Mindfulness Based Cognitive Therapy in people with Smoking Cessation and Tobacco Dependence, run by University of Pittsburgh 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 9 inclusion and 4 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 31 May 2017. 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?

Feasibility of recruitment and retention of participants (time frame: baseline - session 8 and 6 month follow-up). The study lists 2 primary outcomes in all. 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 NCT00449293, which also lists 7 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 31 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in