Effects of Brief Training on Craving Regulation

Yale University

Status: Completed

Conditions: Nicotine Addiction

Treatments: Behavioral: Cognitive Regulation of Craving; Behavioral: Mindfulness-Based Regulation of Craving

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02153749

1210010970

P50DA009241 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 3 patient groups

Cognitive Regulation of Craving

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Regulation of Craving

Mindfulness-Based Regulation of Craving

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Regulation of Craving

No training control

No Intervention group

Description:

No training sessions will be provided in this arm.