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Effects of Brief Training on Craving Regulation

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Yale University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02153749
First received: May 23, 2014
Last updated: December 6, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Nicotine Addiction Behavioral: Cognitive Regulation of Craving Behavioral: Mindfulness-Based Regulation of Craving

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Self-report Craving level [ Time Frame: Baseline to 4 weeks ]
    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).

  • % change in craving and control related neural activity measured via fMRI [ Time Frame: Baseline to 4 weeks ]
    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).

  • Change in Smoking [ Time Frame: baseline to 4 weeks ]
    Measurement of reduction in cigarette smoking, measured by self report/cotinine/CO2, and FTND smoking severity


Secondary Outcome Measures:
  • Change in Cognitive Control & Affective Reactivity Behavioral Assessments [ Time Frame: baseline to 4 weeks ]
    Detection of generalized effects of the training on affective reactivity and cognitive control, including: (1) Distress Tolerance, (2) CANTAB neuropsychological assessments, and (3) Drug Risk Response Task (DRRT) to measure regulation skills acquisition.

  • Change in general neural activity measured via fMRI [ Time Frame: Baseline to 4 weeks ]
    Determination if the effects of training generalize to other measures of cognitive control/distress tolerance, using fMRI task neural activity.


Other Outcome Measures:
  • Gender [ Time Frame: 4 weeks ]
    Whether gender moderates any of the findings


Estimated Enrollment: 126
Study Start Date: September 2015
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Regulation of Craving
Training in craving regulation component of Cognitive Behavioral Therapy(CBT) for addictions.
Behavioral: Cognitive Regulation of Craving
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.
Experimental: Mindfulness-Based Regulation of Craving
Training in craving regulation component of Mindfulness Based Therapy(MBT) for addiction.
Behavioral: Mindfulness-Based Regulation of Craving
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.
No Intervention: No training control
No training sessions will be provided in this arm.

Detailed Description:
The investigators propose to test the efficacy of such training by randomizing 126 cigarette smokers to the following conditions: 1) brief training in cognitive regulation of craving 2) mindfulness-based training, and 3) control or no training. Training will be delivered in 6x1 hour computerized sessions over four weeks. Control subjects simply fill out assessments during their visits. Participants who were randomized into the cognitive or mindfulness training complete Regulation of Craving (ROC) training sessions of approximately 60-90 minutes. If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy that instructs them to think of all the negative outcomes associated with continued cigarette smoking. If randomized into the MBT-based regulation training, subjects will be trained to use a mindfulness strategy that instructs them to notice and accept their feelings of craving without judgment or intent to act upon them. After all training sessions are completed, there is a 4 week and 12 week follow-up. The investigators will evaluate the effects of training on craving and regulation of craving measured by self-report and functional magnetic resonance imaging during the Regulation of Craving(ROC) task administered pre- and post- treatment, as well as smoking.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current or past comorbid Axis I disorders (assessed via the Mini Psychiatric Interview Diagnosis; MINI)
  2. 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).
  3. Serious or unstable medical condition within past 6 months
  4. Use of an investigational drug currently or within past 30 days
  5. Use of psychoactive medications or those that affect blood flow
  6. 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).
  7. For females only: pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153749

Contacts
Contact: Matthew G Schafer, B.A. 203-737-4714 matthew.schafer@yale.edu
Contact: Shosuke Suzuki, B.S. 203-737-4714 shosuke.suzuki@yale.edu

Locations
United States, Connecticut
Clinical & Affective Neuroscience Lab Recruiting
New Haven, Connecticut, United States, 06510
Contact: Matthew Schafer, B.A.    203-737-4714    matthew.schafer@yale.edu   
Contact: Shosuke Suzuki, B.S.    2037374714    shosuke.suzuki@yale.edu   
Principal Investigator: Hedy Kober, Ph.D.         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Hedy Kober, Ph.D. Yale School of Medicine
  More Information

Publications:
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.

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02153749     History of Changes
Other Study ID Numbers: HIC #1210010970
P50DA009241 ( U.S. NIH Grant/Contract )
Study First Received: May 23, 2014
Last Updated: December 6, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on July 21, 2017