NCT07768007|RecruitingFDA Device
Real-time Opioid Study
Neurofeedback to Reduce Anhedonia and Improve Outcomes in Opioid Use Disorder: a Feasibility Study
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Neurofeedback to Reduce Anhedonia and Improve Outcomes in Opioid Use Disorder: a Feasibility Study
Sponsor study identifier
interventional
3
1 country
1
Study Start
September 8, 2026
Actual (reported)Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2026
Actual (reported)August 17, 2026
Actual (reported)September 8, 2026
Actual (reported)February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of participants who completed the intervention
Number of participants who completed the full intervention of those enrolled.
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.
Up to one month post second neurofeedback session
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
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
Participants will complete five study visits. They will receive neurofeedback at two separate scanning sessions (sessions 2-3). Neurofeedback scans will include rest, neurofeedback, and transfer (i.e., no feedback) runs, one week apart.
A non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
APT Foundation
New Haven, Connecticut, 06520, United States
Michelle Hampson, PhD
Yale University
Kathleen Garrison, PhD
Yale University
First Submitted
August 11, 2026
First Posted
August 17, 2026
Study Start
September 8, 2026
Actual (reported)Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Neuromodulation in Substance Use Disorders
Contact the study team to confirm eligibility.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 14, 2026
Record last verified: 2026-09
De-identified data will be shared with other researchers.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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