Effects of Brief Training on Craving Regulation



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:1/12/2019
Start Date:September 2015
End Date:August 2020
Contact:Nilo Vafay, M.S.
Email:nilo.vafay@yale.edu
Phone:203-737-4714

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Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms

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.

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.

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.
We found this trial at
1
site
New Haven, Connecticut 06510
Principal Investigator: Hedy Kober, Ph.D.
Phone: 203-737-4714
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mi
from
New Haven, CT
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