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Recruiting NCT06440577

Craving & Decision-Making

No phase Interventional Decision Making

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audio-visual stimuli (Neutral-Relaxing), Audio-visual stimuli (Drug), Audio-visual stimuli (Non-Food), Audio-visual stimuli (Food).
Who it may be relevant to
Registry conditions: Decision Making. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Decision Neuroscience of Craving

Overview

Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants.

Interventions

  • Behavioral Audio-visual stimuli (Neutral-Relaxing)
    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).
  • Behavioral Audio-visual stimuli (Drug)
    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.
  • Behavioral Audio-visual stimuli (Non-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.
  • Behavioral 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 a snack (e.g., chocolate bar, bag of chips) and taking out its contents.

Primary outcome measures

  • Willingness-to-pay [Time frame: during the task]
  • fMRI-BOLD activity measured during willingness-to-pay decisions [Time frame: during the task]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Rutgers, The State University of New Jersey — Piscataway

Identifiers

NCT: NCT06440577 · Pro2018002176 · R01DA054201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗