Effects of Brief Training on Craving Regulation
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|ClinicalTrials.gov Identifier: NCT02153749|
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Addiction||Behavioral: Cognitive Regulation of Craving Behavioral: Mindfulness-Based Regulation of Craving||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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.
- 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
- 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.
- Gender [ Time Frame: 4 weeks ]Whether gender moderates any of the findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153749
|Contact: Matthew G Schafer, B.A.||firstname.lastname@example.org|
|Contact: Shosuke Suzuki, B.S.||email@example.com|
|United States, Connecticut|
|Clinical & Affective Neuroscience Lab||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Matthew Schafer, B.A. 203-737-4714 firstname.lastname@example.org|
|Contact: Shosuke Suzuki, B.S. 2037374714 email@example.com|
|Principal Investigator: Hedy Kober, Ph.D.|
|Principal Investigator:||Hedy Kober, Ph.D.||Yale School of Medicine|