Craving & Decision-Making

NCT ID: NCT06440577

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decision Making

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Men and women with OUD receiving medications for OUD treatment will complete both the Consumer Items Willingness-to-Pay Task and Snack Foods Willingness-to-Pay Task at two separate task sessions. Non-psychiatric community control participants will complete the Snack Foods Willingness-to-Pay Task.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Audio-visual stimuli (Neutral-Relaxing)

Intervention Type BEHAVIORAL

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-visual stimuli (Drug)

Intervention Type BEHAVIORAL

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.

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).

Group Type EXPERIMENTAL

Audio-visual stimuli (Non-Food)

Intervention Type BEHAVIORAL

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-visual stimuli (Food)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna B. Konova, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Konova, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rutgers, The State University of New Jersey

Piscataway, New Jersey, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Konova, PhD

Role: CONTACT

732-235-4335

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna Konova, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA054201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2018002176

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurobehavioral Mechanisms of Cocaine Choice
NCT04296006 COMPLETED EARLY_PHASE1
Targeting Drug Memories With Methylphenidate
NCT05978167 ACTIVE_NOT_RECRUITING EARLY_PHASE1