Craving & Decision-Making

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Decision Making

Treatments: Behavioral: Audio-visual stimuli (Non-Food); Behavioral: Audio-visual stimuli (Drug); Behavioral: Audio-visual stimuli (Food); Behavioral: Audio-visual stimuli (Neutral-Relaxing)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06440577

Pro2018002176

R01DA054201 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Consumer Items Willingness-to-Pay Task

Experimental group

Description:

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).

Treatment:

Behavioral: Audio-visual stimuli (Neutral-Relaxing)

Behavioral: Audio-visual stimuli (Drug)

Snack Foods Willingness-to-Pay Task

Experimental group

Description:

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).

Treatment:

Behavioral: Audio-visual stimuli (Food)

Behavioral: Audio-visual stimuli (Non-Food)