Real-time Opioid Study

Yale University3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Substance Use Disorder (SUD)

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥3 months of methadone treatment for OUD * Presence of anhedonia, as assessed via SHAPS * Room for improvement in specific autobiographical memory recall, 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

Locations (1)

APT Foundation

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants who completed the intervention

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

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

Self-report ratings of tolerability

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.

Time frame: Up to one month post second neurofeedback session

Secondary Outcomes

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

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

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

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

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

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

Central Contacts

Sarah Paprotna

CONTACT

+1 (203) 737-5994 sarah.paprotna@yale.edu

Data from ClinicalTrials.gov

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