NCT02153749

Brief Summary

The investigators propose that brief training in regulation of craving may increase the efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based strategies may operate via different psychological and neural mechanisms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

May 23, 2014

Last Update Submit

April 9, 2020

Conditions

Nicotine Addiction

Outcome Measures

Primary Outcomes (3)

  • Change in Self-report Craving level

    ROC task performance, as change from pre- to post- training in (1) craving (operationalized as self-reported craving on craving trials). (2) strategy-specific regulation (operationalized as scores on regulation trials using the trained strategy: LATER/control trials for CBT-based training, ACCEPT/mindfulness trials for MBT-based training). (3) strategy-non-specific regulation (scores on regulation - using the non-trained strategy: LATER trials for MBT-based training, ACCEPT trials for CBT-based training).

    Baseline to 4 weeks

  • % change in craving and control related neural activity measured via functional magnetic resonance imaging (fMRI).

    The neural activity component will be calculated as change from pre-to post- training during fMRI ROC task, including (1) craving- related activity (operationalized as neural reactivity in "craving regions" including Ventral Striatum, ventral medial Pre-Frontal Cortex); (2) neural substrates of control during regulation of craving (operationalized as neural activity in "control regions" including dorsal lateral and ventral lateral prefrontal cortex).

    Baseline to 4 weeks

  • Change in Smoking

    Measurement of reduction in cigarette smoking, measured by self report/cotinine/Carbon dioxide(CO2), and FTND smoking severity

    baseline to 4 weeks

Secondary Outcomes (2)

  • Change in Cognitive Control & Affective Reactivity Behavioral Assessments

    baseline to 4 weeks

  • Change in general neural activity measured via fMRI

    Baseline to 4 weeks

Other Outcomes (1)

  • Gender

    4 weeks

Study Arms (3)

Cognitive Regulation of Craving

EXPERIMENTAL

Training in craving regulation component of Cognitive Behavioral Therapy(CBT) for addictions.

Behavioral: Cognitive Regulation of Craving

Mindfulness-Based Regulation of Craving

EXPERIMENTAL

Training in craving regulation component of Mindfulness Based Therapy(MBT) for addiction.

Behavioral: Mindfulness-Based Regulation of Craving

No training control

NO INTERVENTION

No training sessions will be provided in this arm.

Interventions

Cognitive Regulation of CravingBEHAVIORAL

Regulation strategy practice: Participants will be trained to use a CBT-based cognitive regulation strategy. They will be asked to think of their individualized negative consequences for and thing of them when they see the instruction "LATER" during the task. Participants will practice using this strategy for multiple cigarette stimuli. High-Risk Situation Practice: Participants will identify 10 situations in which they usually smoke, or are likely to smoke in the next 48 hours. For each situation, they will be asked to practice using the strategy and to plan to use this strategy to regulate craving in daily life.

Cognitive Regulation of Craving
Mindfulness-Based Regulation of CravingBEHAVIORAL

Each training session in this condition will be identical to the CBT-based training session described, with the exception of the strategy being trained. Specifically, participants will be trained in using the MBT-based strategy ("notice craving and accept the feeling without judgment or reaction"). To do so, they will be asked to generate their own non- reactive responses to craving (e.g., "I can just sit here and notice this. I can ask myself, 'can I be ok with this feeling?'") Participants will then be instructed to think of those accepting and non-reactive responses when they see the instruction "ACCEPT" during the task. All other components will be identical.

Mindfulness-Based Regulation of Craving

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 60
  • Smoking 10 or more cigarettes per day,
  • Score \>4 on the Fagerstrom Test For Nicotine Dependence (FTND)
  • Treatment seeking (motivated to quit or reduce smoking; \>6 on a 10 point likert scale)
  • Fluent English speaker
  • Can commit to the full length of the protocol (\~8 weeks) and
  • Are willing to be randomized to treatment condition.

You may not qualify if:

  • Current or past comorbid Axis I disorders (assessed via the Mini Psychiatric Interview Diagnosis; MINI)
  • Current use of any psychoactive medications that have not been at a stable dose for the past 6 months, are used as mood stabilizers, or are used as smoking cessation treatments (e.g. varenicline).
  • Serious or unstable medical condition within past 6 months
  • Use of an investigational drug currently or within past 30 days
  • Use of psychoactive medications or those that affect blood flow
  • Other conditions contra-indicated for MRI (e.g., claustrophobia, presence of ferromagnetic metal in the body, prior head trauma with loss of consciousness, color blindness, hypertension, pregnancy).
  • For females only: pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, 06510, United States

Location

Related Publications (10)

  • Witkiewitz K, Bowen S, Douglas H, Hsu SH. Mindfulness-based relapse prevention for substance craving. Addict Behav. 2013 Feb;38(2):1563-1571. doi: 10.1016/j.addbeh.2012.04.001. Epub 2012 Apr 6.

    PMID: 22534451BACKGROUND

  • Ferguson SG, Shiffman S. The relevance and treatment of cue-induced cravings in tobacco dependence. J Subst Abuse Treat. 2009 Apr;36(3):235-43. doi: 10.1016/j.jsat.2008.06.005. Epub 2008 Aug 20.

    PMID: 18715743BACKGROUND

  • Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.

    PMID: 23265088BACKGROUND

  • Carroll KM. Therapy Manuals for Drug Addiction. A Cognitive-Behavioral Approach: Treating Cocaine Addiction. In: Abuse NIoD, ed. Bethesda, MD: National Institute of Drug Abuse; 1998.

    BACKGROUND

  • Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.

    PMID: 21723049BACKGROUND

  • Kober H, Kross EF, Mischel W, Hart CL, Ochsner KN. Regulation of craving by cognitive strategies in cigarette smokers. Drug Alcohol Depend. 2010 Jan 1;106(1):52-5. doi: 10.1016/j.drugalcdep.2009.07.017. Epub 2009 Sep 11.

    PMID: 19748191BACKGROUND

  • Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2.

    PMID: 20679212BACKGROUND

  • Westbrook C, Creswell JD, Tabibnia G, Julson E, Kober H, Tindle HA. Mindful attention reduces neural and self-reported cue-induced craving in smokers. Soc Cogn Affect Neurosci. 2013 Jan;8(1):73-84. doi: 10.1093/scan/nsr076. Epub 2011 Nov 22.

    PMID: 22114078BACKGROUND

  • Tang YY, Tang R, Posner MI. Brief meditation training induces smoking reduction. Proc Natl Acad Sci U S A. 2013 Aug 20;110(34):13971-5. doi: 10.1073/pnas.1311887110. Epub 2013 Aug 5.

    PMID: 23918376BACKGROUND

  • Roos CR, Harp NR, Vafaie N, Gueorguieva R, Frankforter T, Carroll KM, Kober H. Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. Psychol Addict Behav. 2023 Nov;37(7):829-840. doi: 10.1037/adb0000940. Epub 2023 Aug 3.

    PMID: 37535555DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Hedy Kober, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 3, 2014

Study Start

September 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

US(1)