Substance Use Disorder (SUD)
Conditions
Brief summary
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.
Interventions
DEVICEreal-time functional magnetic resonance imaging (rt-fMRI) neurofeedback
A non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who completed the intervention | Through study completion, up to one month post second neurofeedback session | Number of participants who completed the full intervention of those enrolled. |
| Self-report ratings of tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of positive memories recalled as assessed by Autobiographical Memory Test (AMT) | 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. |
| Changes in anhedonia, as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS) | 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). |
Countries
United States
Contacts
CONTACTSarah Paprotna
PRINCIPAL_INVESTIGATORMichelle Hampson, PhD
Yale University
PRINCIPAL_INVESTIGATORKathleen Garrison, PhD
Yale University
Outcome results
None listed