Trial · NCT04188288
Neurofeedback in Individuals With Substance Use Disorders
NCT04188288, Not applicable, Terminated, Yale University; results first posted 2024-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neurofeedback in Individuals With Substance Use Disorders. Trials, record NCT04188288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04188288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neurofeedback in Individuals With Substance Use Disorders
- NCT number
- NCT04188288
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 12 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Opioid-Related Disorders
- Interventions
- Experimental feedback, Control feedback, fMRI
- First posted
- 2019-12-05
- Last updated
- 2024-09-25
- Results first posted
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Opioid Use: Urine Tests | Baseline (week 1) to one month post follow-up (week 9) | Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests. |
| Primary | Opioid Use: Timeline Followback Method (TLFB) | Baseline (week 1) to one month post follow-up (week 9) | 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. |
| Secondary | Mean Change in Functional Connectivity Patterns in the Brain | Baseline (week 1) through follow up (week 5) | 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. |
| Secondary | Mean Opioid Craving Score | Baseline (week 1) to one month post follow-up (*week 9*) | 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. |
| Secondary | Negative Affect Mean Score | Baseline (week 1) to one month post follow-up (week 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Opioid Use: Urine Tests | Baseline (week 1) to one month post follow-up (week 9) | One participant in the experimental group did not have any urine tests. | percentage of negative tests | NUMBER |
| PRIMARY | Opioid Use: Timeline Followback Method (TLFB) | Baseline (week 1) to one month post follow-up (week 9) | Results presented here are for participants that had completed TLFB at both baseline and follow up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Functional Connectivity Patterns in the Brain | Baseline (week 1) through follow up (week 5) | 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. | Fisher Z-transform corr. coefficient | MEAN |
| SECONDARY | Mean Opioid Craving Score | Baseline (week 1) to one month post follow-up (*week 9*) | Results presented here is for participants that have both baseline and follow up data. | score on a scale | MEAN |
| SECONDARY | Negative Affect Mean Score | Baseline (week 1) to one month post follow-up (week 9) | Results presented here is for participants that have both baseline and follow up data. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Opioid Use: Urine Tests | Neurofeedback | 17.9 | percentage of negative tests | ||
| Opioid Use: Urine Tests | Control Feedback | 0 | percentage of negative tests | ||
| Opioid Use: Timeline Followback Method (TLFB) | Neurofeedback | Baseline / Negative | 1 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Control Feedback | Baseline / Negative | 1 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Neurofeedback | Baseline / Positive | 1 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Control Feedback | Baseline / Positive | 1 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Neurofeedback | Follow up / Negative | 0 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Control Feedback | Follow up / Negative | 0 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Neurofeedback | Follow up / Positive | 2 | Participants | |
| Opioid Use: Timeline Followback Method (TLFB) | Control Feedback | Follow up / Positive | 2 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neurofeedback | 8 | |
| Overall Study | STARTED | Control Feedback | 3 | |
| Overall Study | Completed Scan Day 1 | Neurofeedback | 7 | |
| Overall Study | Completed Scan Day 1 | Control Feedback | 3 | |
| Overall Study | Completed Scan Day 2 | Neurofeedback | 5 | |
| Overall Study | Completed Scan Day 2 | Control Feedback | 3 | |
| Overall Study | Completed Scan Day 3 | Neurofeedback | 4 | |
| Overall Study | Completed Scan Day 3 | Control Feedback | 3 | |
| Overall Study | Completed Scan Day 4 | Neurofeedback | 4 | |
| Overall Study | Completed Scan Day 4 | Control Feedback | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neurofeedback | 0 | 8 |
| Total, all-cause mortality | Control Feedback | 0 | 3 |
| Total, other adverse events | Neurofeedback | 0 | 8 |
| Total, other adverse events | Control Feedback | 0 | 3 |
| Total, serious adverse events | Neurofeedback | 0 | 8 |
| Total, serious adverse events | Control Feedback | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K01DA039299 | Neural mechanisms of galantamine treatment for cocaine dependence | YIP, SARAH | YALE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Neurofeedback vs Control Feedback: deaths from any cause | Trial comparisons |
| Neurofeedback vs Control Feedback: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04188288
GET https://conductscience.org/api/trials/v1/NCT04188288/registered