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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DA039299-01A1 | U.S. NIH Grant/Contract | View source |
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Due to low enrollment from the COVID interruption.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental | Three imaging (fMRI) sessions of experimental feedback. |
|
| Control feedback | Other | Three imaging (fMRI) sessions of control feedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental feedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use: Urine Tests | Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests. | 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. | Baseline (week 1) to one month post follow-up (week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Garrison, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06512 | United States |
12 participants enrolled with one participant excluded prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurofeedback | Three imaging (fMRI) sessions of experimental feedback. Experimental feedback: 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. |
| FG001 | Control Feedback | Three imaging (fMRI) sessions of control feedback. Control feedback (sham): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurofeedback | Three imaging (fMRI) sessions of experimental feedback. Experimental feedback: 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. |
| BG001 | Control Feedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use: Urine Tests | Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests. | One participant in the experimental group did not have any urine tests. | Posted | Number | percentage of negative tests | Baseline (week 1) to one month post follow-up (week 9) | urine tests | urine tests |
|
2 months
No adverse events and/or serious adverse events took place.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurofeedback | Three imaging (fMRI) sessions of experimental feedback. Experimental feedback: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Garrison, PhD | Yale University | 203-737-6232 | kathleen.garrison@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2022 | Mar 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2022 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Participants will be blinded as to whether they are receiving experimental or control neurofeedback.
| Control feedback | Device | 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 | Device | fMRI will be used to assess brain activity |
|
| 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. | 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. | Baseline (week 1) to one month post follow-up (week 9) |
Three imaging (fMRI) sessions of control feedback. Control feedback (sham): 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Opioid Craving Scale | 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
Three imaging (fMRI) sessions of control feedback.
Control feedback (sham): 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.
|
|
| Primary | 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. | Results presented here are for participants that had completed TLFB at both baseline and follow up. | Posted | Count of Participants | Participants | Baseline (week 1) to one month post follow-up (week 9) |
|
|
|
| Secondary | 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. | Results are reported for resting state as task data was not able to be collected as planned and for participants that completed all 5 scans. | Posted | Mean | Standard Deviation | Fisher Z-transform corr. coefficient | Baseline (week 1) through follow up (week 5) |
|
|
|
| Secondary | 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. | Results presented here is for participants that have both baseline and follow up data. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 1) to one month post follow-up (*week 9*) |
|
|
|
| Secondary | 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. | Results presented here is for participants that have both baseline and follow up data. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 1) to one month post follow-up (week 9) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control Feedback | Three imaging (fMRI) sessions of control feedback. Control feedback (sham): 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Follow up |
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