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NCT Number: NCT07768007

Real-time Opioid Study

This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting first-in-human data in an OUD population. Investigators will assess tolerability of the intervention and collect preliminary data from 2-3 subjects monitoring changes in anhedonia, non-substance-related autobiographical memory recall, and meaning in life.

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Key information

Conditions

Substance Use Disorder (SUD) Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APT Foundation

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥3 months of methadone treatment for OUD
  • Presence of anhedonia, as assessed via SHAPS
  • Baseline autobiographical memory deficit, as assessed via AMT

Exclusion criteria

  • Failure to pass an MRI screening
  • Women who are pregnant
  • Psychosis, as assessed via Yale PRIME Early Psychosis Screening Test
  • Serious suicidal ideation
  • Serious medical condition
  • Legally blind

Treatment and study plan

real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback

Device

A non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.

Primary outcomes

  1. Number of participants who completed the intervention

    Time frame: Through study completion, up to one month post second neurofeedback session

    Number of participants who completed the full intervention of those enrolled.

  2. Self-report ratings of tolerability

    Time frame: Up to one month post second neurofeedback session

    Questionnaire where participants indicate how worthwhile participating in the study was on a 1-7 Likert scale. Total score range 1-7 with higher numbers indicating greater tolerability.

Secondary outcomes

  1. Percentage of positive memories recalled as assessed by Autobiographical Memory Test (AMT)

    Time frame: Baseline, one week post second neurofeedback session and one month post second neurofeedback session

    A psychological assessment used to measure how specifically an individual can recall positive personal, life-related events.

  2. Changes in anhedonia, as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: Baseline, one week post second neurofeedback session and one month post second neurofeedback session

    Total score range 0-14 with higher scores reflecting a higher level of anhedonia (the inability to experience pleasure).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Paprotna

CONTACT

[email protected]

+1 (203) 737-5994

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Neurofeedback to Reduce Anhedonia and Improve Outcomes in Opioid Use Disorder: a Feasibility Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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