Trial Outcomes & Findings for Neurofeedback in Individuals With Substance Use Disorders (NCT NCT04188288)
NCT ID: NCT04188288
Last Updated: 2024-09-25
Results Overview
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
TERMINATED
NA
12 participants
Baseline (week 1) to one month post follow-up (week 9)
2024-09-25
Participant Flow
12 participants enrolled with one participant excluded prior to randomization
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
Completed Scan Day 1
|
7
|
3
|
|
Overall Study
Completed Scan Day 2
|
5
|
3
|
|
Overall Study
Completed Scan Day 3
|
4
|
3
|
|
Overall Study
Completed Scan Day 4
|
4
|
3
|
|
Overall Study
Completed Scan Day 5
|
2
|
3
|
|
Overall Study
Completed 1 Month Follow up
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurofeedback in Individuals With Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Neurofeedback
n=8 Participants
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.
|
Control Feedback
n=3 Participants
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Opioid Craving Scale
|
17.4 score on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
16.8 score on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
17.2 score on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Quick Inventory of Depressive Symptomatology
|
9.0 score on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
8.7 score on a scale
STANDARD_DEVIATION 4.9 • n=7 Participants
|
8.9 score on a scale
STANDARD_DEVIATION 5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 1) to one month post follow-up (week 9)Population: One participant in the experimental group did not have any urine tests.
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
Outcome measures
| Measure |
Neurofeedback
n=12 urine tests
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.
|
Control Feedback
n=5 urine tests
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.
|
|---|---|---|
|
Opioid Use: Urine Tests
|
17.9 percentage of negative tests
|
0 percentage of negative tests
|
PRIMARY outcome
Timeframe: Baseline (week 1) to one month post follow-up (week 9)Population: Results presented here are for participants that had completed TLFB at both baseline and follow up.
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.
Outcome measures
| Measure |
Neurofeedback
n=2 Participants
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.
|
Control Feedback
n=2 Participants
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.
|
|---|---|---|
|
Opioid Use: Timeline Followback Method (TLFB)
Follow up · Positive
|
2 Participants
|
2 Participants
|
|
Opioid Use: Timeline Followback Method (TLFB)
Baseline · Negative
|
1 Participants
|
1 Participants
|
|
Opioid Use: Timeline Followback Method (TLFB)
Baseline · Positive
|
1 Participants
|
1 Participants
|
|
Opioid Use: Timeline Followback Method (TLFB)
Follow up · Negative
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 1) through follow up (week 5)Population: 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.
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.
Outcome measures
| Measure |
Neurofeedback
n=2 Participants
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.
|
Control Feedback
n=3 Participants
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.
|
|---|---|---|
|
Mean Change in Functional Connectivity Patterns in the Brain
|
-11.2 Fisher Z-transform corr. coefficient
Standard Deviation 13.4
|
38.7 Fisher Z-transform corr. coefficient
Standard Deviation 67.7
|
SECONDARY outcome
Timeframe: Baseline (week 1) to one month post follow-up (*week 9*)Population: Results presented here is for participants that have both baseline and follow up data.
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.
Outcome measures
| Measure |
Neurofeedback
n=2 Participants
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.
|
Control Feedback
n=3 Participants
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.
|
|---|---|---|
|
Mean Opioid Craving Score
Baseline
|
18.8 score on a scale
Standard Deviation 7.9
|
16.8 score on a scale
Standard Deviation 7.6
|
|
Mean Opioid Craving Score
Follow up
|
23.8 score on a scale
Standard Deviation 5.5
|
16.0 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline (week 1) to one month post follow-up (week 9)Population: Results presented here is for participants that have both baseline and follow up data.
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.
Outcome measures
| Measure |
Neurofeedback
n=2 Participants
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.
|
Control Feedback
n=3 Participants
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.
|
|---|---|---|
|
Negative Affect Mean Score
Follow up
|
14.5 score on a scale
Standard Deviation 2.1
|
6.7 score on a scale
Standard Deviation 2.5
|
|
Negative Affect Mean Score
Baseline
|
12 score on a scale
Standard Deviation 1.4
|
8.7 score on a scale
Standard Deviation 4.9
|
Adverse Events
Neurofeedback
Control Feedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place