Effects of Brief Training on Craving Regulation

NCT ID: NCT02153749

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-07-31

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.

Conditions

Nicotine Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Regulation of Craving

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

Group Type: EXPERIMENTAL

Cognitive Regulation of Craving

Intervention Type: BEHAVIORAL

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.

Mindfulness-Based Regulation of Craving

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

Group Type: EXPERIMENTAL

Mindfulness-Based Regulation of Craving

Intervention Type: BEHAVIORAL

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 training control

No training sessions will be provided in this arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hedy Kober, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, United States

Countries

United States

References

Witkiewitz K, Bowen S, Douglas H, Hsu SH. Mindfulness-based relapse prevention for substance craving. Addict Behav. 2013 Feb;38(2):1563-1571. doi: 10.1016/j.addbeh.2012.04.001. Epub 2012 Apr 6.

Reference Type: BACKGROUND

PMID: 22534451 (View on PubMed)

Ferguson SG, Shiffman S. The relevance and treatment of cue-induced cravings in tobacco dependence. J Subst Abuse Treat. 2009 Apr;36(3):235-43. doi: 10.1016/j.jsat.2008.06.005. Epub 2008 Aug 20.

Reference Type: BACKGROUND

PMID: 18715743 (View on PubMed)

Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.

Reference Type: BACKGROUND

PMID: 23265088 (View on PubMed)

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.

Reference Type: BACKGROUND

Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.

Reference Type: BACKGROUND

PMID: 21723049 (View on PubMed)

Kober H, Kross EF, Mischel W, Hart CL, Ochsner KN. Regulation of craving by cognitive strategies in cigarette smokers. Drug Alcohol Depend. 2010 Jan 1;106(1):52-5. doi: 10.1016/j.drugalcdep.2009.07.017. Epub 2009 Sep 11.

Reference Type: BACKGROUND

PMID: 19748191 (View on PubMed)

Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2.

Reference Type: BACKGROUND

PMID: 20679212 (View on PubMed)

Westbrook C, Creswell JD, Tabibnia G, Julson E, Kober H, Tindle HA. Mindful attention reduces neural and self-reported cue-induced craving in smokers. Soc Cogn Affect Neurosci. 2013 Jan;8(1):73-84. doi: 10.1093/scan/nsr076. Epub 2011 Nov 22.

Reference Type: BACKGROUND

PMID: 22114078 (View on PubMed)

Tang YY, Tang R, Posner MI. Brief meditation training induces smoking reduction. Proc Natl Acad Sci U S A. 2013 Aug 20;110(34):13971-5. doi: 10.1073/pnas.1311887110. Epub 2013 Aug 5.

Reference Type: BACKGROUND

PMID: 23918376 (View on PubMed)

Roos CR, Harp NR, Vafaie N, Gueorguieva R, Frankforter T, Carroll KM, Kober H. Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. Psychol Addict Behav. 2023 Nov;37(7):829-840. doi: 10.1037/adb0000940. Epub 2023 Aug 3.

Reference Type: DERIVED

PMID: 37535555 (View on PubMed)

Other Identifiers

P50DA009241

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1210010970

Identifier Type: -

Identifier Source: org_study_id