Real-time Opioid Study
ConditionSubstance Use Disorder (SUD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
Failure to pass an MRI screening
Women who are pregnant
Psychosis, as assessed via Yale PRIME Early Psychosis Screening Test
Serious suicidal ideation
Trial design
Design model
Single group
Treatments tested in this trial
real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback
DeviceA non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Individuals with OUDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 session2
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 sessionSecondary outcomes
1
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 session2
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 sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov