Effects of Brief Training on Craving Regulation

Study Overview
=================
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.

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.

Official Title
-----------------
Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms

Conditions
-----------------
Nicotine Addiction

Intervention / Treatment
-----------------
* Behavioral: Cognitive Regulation of Craving
* Behavioral: Mindfulness-Based Regulation of Craving


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Regulation of Craving<br>Training in craving regulation component of Cognitive Behavioral Therapy(CBT) for addictions. | Behavioral: Cognitive Regulation of Craving<br>* 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.<br>|
| Experimental: Mindfulness-Based Regulation of Craving<br>Training in craving regulation component of Mindfulness Based Therapy(MBT) for addiction. | Behavioral: Mindfulness-Based Regulation of Craving<br>* 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.<br>|
| No Intervention: No training control<br>No training sessions will be provided in this arm. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Control & Affective Reactivity Behavioral Assessments | 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. | baseline to 4 weeks | 
| Change in general neural activity measured via fMRI | Determination if the effects of training generalize to other measures of cognitive control/distress tolerance, using fMRI task neural activity. | Baseline to 4 weeks |