Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Binge Eating and Smoking

NCT03353649 | Completed

• 2 other identifiers: 5UH2DA041713-02UH2DA041713
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine targets of self-regulatory function among two exemplar populations for which behavior plays a critical role in health outcomes: smokers and individual who binge eat (BED). This is the second phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.

Conditions

Binge Eating; Smoking, Tobacco; Behavior

Outcome Measures

Primary Outcomes (3)

• Behavioral Regulation

  Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The degree to which subjects can regulate their desire to consume their stimulus of value after a later cue is evidence of successful self regulation.

  A single 1.5 hour session for each subject

• Regulation of fMRI activation

  Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI activation relating to this interaction is taken as the activation-based neural underpinnings of self-regulation.

  A single 1.5 hour session for each subject

• Changes in fMRI functional connectivity

  Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI functional connectivity changes relating to this interaction is taken as the connectivity-based neural underpinnings of self-regulation.

  A single 1.5 hour session for each subject

Study Arms (2)

Binge Eating Group

EXPERIMENTAL

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. Specifically, participants in this sample will be exposed to images of food and control non-food images. In different trials, subjects will be given a "now" cue instructing them to engage with the immediate hedonic properties of the stimulus or a "later" cue instructing them to imagine the long-term consequences of using the stimulus. This arm includes fMRI and the now vs. later cue intervention

Behavioral: Now vs. Later Cue; Device: fMRI

Smoking Group

EXPERIMENTAL

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (tobacco-related images or smokers), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. A similar approach to the Binge Eating sample will be used for the smoking sample using two stimulus sets. Instead of foods and non-food control images, smokers will see smoking-related images and the same control non-food non-smoking images as the Binge Eating sample. This Arm includes fMRI and the now vs. later cue intervention

Behavioral: Now vs. Later Cue; Device: fMRI

Interventions

Now vs. Later Cue BEHAVIORAL

As we collect data from all participants, we will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a "now" cue instructing them to think of immediately using/consuming that stimulus or a "later" cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus.

Binge Eating Group; Smoking Group

fMRI DEVICE

Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.

Binge Eating Group; Smoking Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand English sufficiently to provide informed consent
• Right-handed
• Normal or corrected-to-normal vision and no color blindness
• Smoke 5 or more tobacco cigarettes/day for past year
• BMI greater than or equal to 17 and less than 27
• BMI greater than or equal to 27 and less than 45
• Weight limit of 350 lbs
• Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)

You may not qualify if:

• Significant medical illness
• History of mental disorder due to a medical condition
• Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
• Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
• Lost weight in recent past (\>10 pounds in past 6 months)
• Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
• Currently on a special diet for a serious health condition
• Binge eating behavior

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford CNI

Stanford, California, 94305, United States

Location

Related Publications (19)

• De Jong R, Coles MG, Logan GD. Strategies and mechanisms in nonselective and selective inhibitory motor control. J Exp Psychol Hum Percept Perform. 1995 Jun;21(3):498-511. doi: 10.1037//0096-1523.21.3.498.

  PMID: 7790830 BACKGROUND

• Bissett PG, Logan GD. Balancing cognitive demands: control adjustments in the stop-signal paradigm. J Exp Psychol Learn Mem Cogn. 2011 Mar;37(2):392-404. doi: 10.1037/a0021800.

  PMID: 21171806 BACKGROUND

• Logan GD, Van Zandt T, Verbruggen F, Wagenmakers EJ. On the ability to inhibit thought and action: general and special theories of an act of control. Psychol Rev. 2014 Jan;121(1):66-95. doi: 10.1037/a0035230.

  PMID: 24490789 BACKGROUND

• Hofmann W, Schmeichel BJ, Baddeley AD. Executive functions and self-regulation. Trends Cogn Sci. 2012 Mar;16(3):174-80. doi: 10.1016/j.tics.2012.01.006. Epub 2012 Feb 13.

  PMID: 22336729 BACKGROUND

• MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.

  PMID: 2034749 BACKGROUND

• Stroop, J. R. (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18, 643-662.

  BACKGROUND

• Otto AR, Skatova A, Madlon-Kay S, Daw ND. Cognitive control predicts use of model-based reinforcement learning. J Cogn Neurosci. 2015 Feb;27(2):319-33. doi: 10.1162/jocn_a_00709.

  PMID: 25170791 BACKGROUND

• Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.

  PMID: 11970796 BACKGROUND

• Casey BJ, Jones RM, Hare TA. The adolescent brain. Ann N Y Acad Sci. 2008 Mar;1124:111-26. doi: 10.1196/annals.1440.010.

  PMID: 18400927 BACKGROUND

• Figner B, Mackinlay RJ, Wilkening F, Weber EU. Affective and deliberative processes in risky choice: age differences in risk taking in the Columbia Card Task. J Exp Psychol Learn Mem Cogn. 2009 May;35(3):709-30. doi: 10.1037/a0014983.

  PMID: 19379045 BACKGROUND

• Mayr U, Kliegl R. Differential effects of cue changes and task changes on task-set selection costs. J Exp Psychol Learn Mem Cogn. 2003 May;29(3):362-72. doi: 10.1037/0278-7393.29.3.362.

  PMID: 12776747 BACKGROUND

• Daugherty, J. R., & Brase, G. L. (2010). Taking time to be healthy: Predicting health behaviors with delay discounting and time perspective. Personality and Individual differences, 48(2), 202-207.

  BACKGROUND

• Koffarnus MN, Bickel WK. A 5-trial adjusting delay discounting task: accurate discount rates in less than one minute. Exp Clin Psychopharmacol. 2014 Jun;22(3):222-8. doi: 10.1037/a0035973. Epub 2014 Apr 7.

  PMID: 24708144 BACKGROUND

• Kirby KN, Marakovic NN. Delay-discounting probabilistic rewards: Rates decrease as amounts increase. Psychon Bull Rev. 1996 Mar;3(1):100-4. doi: 10.3758/BF03210748.

  PMID: 24214810 BACKGROUND

• Phillips LH, Wynn VE, McPherson S, Gilhooly KJ. Mental planning and the Tower of London task. Q J Exp Psychol A. 2001 May;54(2):579-97. doi: 10.1080/713755977.

  PMID: 11394063 BACKGROUND

• Shallice T. Specific impairments of planning. Philos Trans R Soc Lond B Biol Sci. 1982 Jun 25;298(1089):199-209. doi: 10.1098/rstb.1982.0082.

  PMID: 6125971 BACKGROUND

• Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

  PMID: 12916575 BACKGROUND

• Hu T, Zhang D, Wang J, Mistry R, Ran G, Wang X. Relation between emotion regulation and mental health: a meta-analysis review. Psychol Rep. 2014 Apr;114(2):341-62. doi: 10.2466/03.20.PR0.114k22w4.

  PMID: 24897894 BACKGROUND

• Lopresti AL, Hood SD, Drummond PD. A review of lifestyle factors that contribute to important pathways associated with major depression: diet, sleep and exercise. J Affect Disord. 2013 May 15;148(1):12-27. doi: 10.1016/j.jad.2013.01.014. Epub 2013 Feb 14.

  PMID: 23415826 BACKGROUND

MeSH Terms

Conditions

Bulimia; Tobacco Smoking; Behavior

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 27, 2017
• Study Start: December 8, 2017
• Primary Completion: January 14, 2018
• Study Completion: January 14, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon submission of the paper detailing the findings of the research
• Access Criteria: All data will be shared openly, with no restrictions on access

Locations

US (1)