Opioid-Related DisordersNCT04188288
Neurofeedback in Individuals With Substance Use Disorders
A study testing Experimental feedback and fMRI in people with Opioid-Related Disorders, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Experimental feedback and fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
- ≥3 months of methadone treatment
Who cannot join
- Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID.
- Failure to pass a magnetic resonance imaging (MRI) screening
- Having significant underlying medical conditions requiring medications.
- Women who are pregnant or nursing
- Baseline scanning with excessive motion based on frame to frame displacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Experimental feedback, Control feedback, fMRI
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental feedbackDevice
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 feedbackDevice
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.
fMRIDevice
fMRI will be used to assess brain activity
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Three imaging (fMRI) sessions of experimental feedback. Receives: Device: Experimental feedback; Device: fMRI |
| Control feedback | Other | Three imaging (fMRI) sessions of control feedback. Receives: Device: Control feedback; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use: Urine Tests
Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
Measured: 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.
Measured: Baseline (week 1) to one month post follow-up (week 9)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 1) to one month post follow-up (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jul 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Due to low enrollment from the COVID interruption.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen Garrison, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188288
- Sponsor's protocol ID
- 2000025618
- Other IDs
- 1K01DA039299-01A1
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2019
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback in Individuals With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT04188288
- Acronym / sponsor ID
- 2000025618
- Conditions
- Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment from the COVID interruption.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Experimental feedback, Device: fMRIThree imaging (fMRI) sessions of experimental feedback. |
| Control feedback | Other | Device: Control feedback, Device: fMRIThree imaging (fMRI) sessions of control feedback. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
- ≥3 months of methadone treatment
Key exclusion criteria (5 listed)
- Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID.
- Failure to pass a magnetic resonance imaging (MRI) screening
- Having significant underlying medical conditions requiring medications.
- Women who are pregnant or nursing
- Baseline scanning with excessive motion based on frame to frame displacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental feedbackParticipants 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. | Device | Neurofeedback |
| Control feedbackParticipants 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. | Device | Control feedback |
| fMRIfMRI will be used to assess brain activity | Device | Control feedback, Neurofeedback |
Primary outcome
Opioid Use: Urine Tests
Time frame: 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.
Opioid Use: Timeline Followback Method (TLFB)
Time frame: 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.
3 secondary outcomes
Mean Change in Functional Connectivity Patterns in the Brain
Time frame: Baseline (week 1) through follow up (week 5)
Mean Opioid Craving Score
Time frame: Baseline (week 1) to one month post follow-up (*week 9*)
Negative Affect Mean Score
Time frame: Baseline (week 1) to one month post follow-up (week 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Garrison, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental feedback and fMRI in people with Opioid-Related Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use: Urine Tests (time frame: Baseline (week 1) to one month post follow-up (week 9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.