An interventional study of Experimental feedback and Control feedback in Opioid-Related Disorders, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
The aim of this study is to train individuals with opioid use disorder to control their brain activity in a way that has been associated with their symptoms. Participants in the experimental group will be given direct feedback regarding their brain activity while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control their brain activity during these feedback sessions. A separate group of participants will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce opioid use and clinical features of opioid use disorder more than the control feedback.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 12 is below the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
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Exclusion Criteria:
Three imaging (fMRI) sessions of experimental feedback.
Device: Experimental feedback · Device: fMRI
Three imaging (fMRI) sessions of control feedback.
Device: Control feedback · Device: fMRI
Participants provided with feedback of target brain activation patterns (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.
Participants provided with control type of feedback (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.
fMRI will be used to assess brain activity
Opioid Use: Urine Tests
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
Time frame: Baseline (week 1) to one month post follow-up (week 9)
Opioid Use: Timeline Followback Method (TLFB)
Opioid use assessed using the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. Number of participants positive or negative for drug use.
Time frame: Baseline (week 1) to one month post follow-up (week 9)
Mean Change in Functional Connectivity Patterns in the Brain
This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans. Opioid abstinence network connectivity strength will be calculated during resting state (H2a). (Data was not able to be collected at MIDT and Stroop tasks as intended.) 0 represents no engagement of the opioid abstinence network. As as a novel brain network measure, there are no defined clinical cutoffs for functional connectivity. Reported is the Z-score Fisher transformed correlation coefficient.
Time frame: Baseline (week 1) through follow up (week 5)
Mean Opioid Craving Score
This outcome will be measured with the Opioid Craving Scale, a 3-item measure of craving that uses a 0-10 analog scale. Total possible score is 0-30, with higher score indicating more craving.
Time frame: Baseline (week 1) to one month post follow-up (*week 9*)
Negative Affect Mean Score
This outcome will be measured by the Quick Inventory of Depressive Symptomatology. This is a 16-item measure, using a 0-3 scale for each item. Total possible score is 0-48, with higher scores indicating greater symptom severity.
Time frame: Baseline (week 1) to one month post follow-up (week 9)
| Milestone | Neurofeedback | Control Feedback |
|---|---|---|
| Started | 8 | 3 |
| Completed scan day 1 | 7 | 3 |
| Completed scan day 2 | 5 | 3 |
| Completed scan day 3 | 4 | 3 |
| Completed scan day 4 | 4 | 3 |
| Completed scan day 5 | 2 | 3 |
| Completed 1 month follow up | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 5 | 0 |
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
| percentage of negative tests | Neurofeedback | Control Feedback |
|---|---|---|
| Opioid Use: Urine Tests | 17.9 | 0 |
Opioid use assessed using the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. Number of participants positive or negative for drug use.
| Participants | Neurofeedback | Control Feedback |
|---|---|---|
| Baseline — Negative | 1 | 1 |
| Baseline — Positive | 1 | 1 |
| Follow up — Negative | 0 | 0 |
| Follow up — Positive | 2 | 2 |
This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans. Opioid abstinence network connectivity strength will be calculated during resting state (H2a). (Data was not able to be collected at MIDT and Stroop tasks as intended.) 0 represents no engagement of the opioid abstinence network. As as a novel brain network measure, there are no defined clinical cutoffs for functional connectivity. Reported is the Z-score Fisher transformed correlation coefficient.
| Fisher Z-transform corr. coefficient | Neurofeedback | Control Feedback |
|---|---|---|
| Mean Change in Functional Connectivity Patterns in the Brain | -11.2 ± 13.4 | 38.7 ± 67.7 |
This outcome will be measured with the Opioid Craving Scale, a 3-item measure of craving that uses a 0-10 analog scale. Total possible score is 0-30, with higher score indicating more craving.
| score on a scale | Neurofeedback | Control Feedback |
|---|---|---|
| Baseline | 18.8 ± 7.9 | 16.8 ± 7.6 |
| Follow up | 23.8 ± 5.5 | 16.0 ± 4.9 |
This outcome will be measured by the Quick Inventory of Depressive Symptomatology. This is a 16-item measure, using a 0-3 scale for each item. Total possible score is 0-48, with higher scores indicating greater symptom severity.
| score on a scale | Neurofeedback | Control Feedback |
|---|---|---|
| Baseline | 12 ± 1.4 | 8.7 ± 4.9 |
| Follow up | 14.5 ± 2.1 | 6.7 ± 2.5 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurofeedback | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control Feedback | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 3 | 11 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 3 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| United States | 8 | 3 | 11 |
| Opioid Craving Scale(score on a scale) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| Mean | 17.4 ± 7.6 | 16.8 ± 7.6 | 17.2 ± 7.2 |
| Quick Inventory of Depressive Symptomatology(score on a scale) | Neurofeedback | Control Feedback | Total |
|---|---|---|---|
| Mean | 9.0 ± 5.4 | 8.7 ± 4.9 | 8.9 ± 5 |
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