Craving & Decision-Making
Decision Neuroscience of Craving
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Anna Konova, PhD
- Phone Number: 732-235-4335
- Email: anna.konova@rutgers.edu
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Recruiting
- Rutgers, The State University of New Jersey
-
Contact:
- Anna Konova, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age
- Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
- Minimum of 6th grade reading level
Additional inclusion criteria for participants with OUD:
- Primary diagnosis of OUD encompassing heroin and/or painkiller use
- Receiving medications for OUD treatment on an outpatient basis
- At least 12-month history of opioid use
Exclusion Criteria:
- Unable to speak or read English
- Active psychosis or mania
- Current or past schizophrenia diagnosis
- History of intellectual disability or developmental or neurological disorder, seizures or epilepsy, or loss consciousness lasting more than 30 minutes
- Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation
- MRI contraindications (claustrophobia, nonremovable piercings, certain metal in the body etc.) or pregnancy
Additional exclusion criteria for community control participants:
- Positive urine drug screen
- Current or past problematic substance use other than nicotine, and alcohol abuse confined to college or military service
- Current or past bipolar disorder diagnosis
- Use of central nervous system medications within the past 6 weeks (e.g., antidepressants, Ritalin)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Consumer Items Willingness-to-Pay Task
Men and women with OUD receiving medications for OUD treatment will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for everyday consumer items that have associations with drug use or not.
Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and drug craving, via two psychological/behavioral interventions: Audio-visual stimuli (Neutral-Relaxing) and Audio-visual stimuli (Drug).
|
Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of neutral everyday objects (e.g., tools, dirt) and their use (construction, gardening).
Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of drug paraphernalia (e.g., syringe, tourniquet, heroin) and preparation.
|
|
Experimental: Snack Foods Willingness-to-Pay Task
Men and women with OUD receiving medications for OUD treatment and control participants from the community will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for snack food items that vary in their features (savory, sweet, etc.).
Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and food craving, via two psychological/behavioral interventions: Audio-visual stimuli (Non-Food) and Audio-visual stimuli (Food).
|
Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping an everyday object (e.g., box of crayons) and taking out its contents.
Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping a snack (e.g., chocolate bar, bag of chips) and taking out its contents.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness-to-pay
Time Frame: during the task
|
The amount that a participant would be willing to pay for different available choice options.
This is measured during the decision-making tasks in which participants are shown images of consumer items or snack foods and report how much they would be willing to pay to have the different items in that moment.
|
during the task
|
|
fMRI-BOLD activity measured during willingness-to-pay decisions
Time Frame: during the task
|
Functional MRI data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in specific regions of interest based on prior research (ventral striatum, ventromedial prefrontal cortex, amygdala, and insula) as participants make willingness-to-pay decisions during each task.
|
during the task
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Anna Konova, PhD, Rutgers, The State University of New Jersey
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Pro2018002176
- R01DA054201 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.