Opioid AddictionPhase 3NCT02696096
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
A Phase 3 study testing FMRI and Suboxone in people with Opioid Addiction, run by Butler Hospital at 1 site in United States.
Trial summary
This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Opioid Addiction
- What is being tested?
- FMRI and Suboxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2020
- Phase
- Phase 3
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- opiate dependent persons
- 21-50 years old
- interested in initiating outpatient buprenorphine treatment
Who cannot join
- current methadone maintenance treatment program participation
- medically necessary prescription opiate treatment (e.g., for chronic pain)
- current criteria for a DSM-V diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
- diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder
- current suicidality on the Modified Scale for Suicidal Ideation
- evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination•
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- anticipated major painful event (significant surgical procedure) in the coming 4 months
- probation or parole requirements or an upcoming move that might interfere with protocol participation
- history of allergic reaction to buprenorphine or naloxone
- currently pregnant or planning to become pregnant in the next 4 months
- history of neurological disorder (e.g., epilepsy, stroke, brain injury)
- impaired uncorrected vision
- FMRI contraindications (e.g., claustrophobia, specific metallic implants and injuries)
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter.
Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).
- Conditions
- Opioid Addiction
- Being tested
- FMRI, Suboxone
- 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.
FMRIOther
Also called functional magnetic resonance imaging
all participants will complete 2 FMRIs
SuboxoneDrug
Also called buprenorphine
all participants will be prescribed Suboxone for 4 months during their study participation
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | FMRI Suboxone Receives: Other: FMRI; Drug: Suboxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
The measure of resting state organization is a z-value derived from Pearson's r-values. They represent the effect of the association between the brain activity of the seed region and each brain voxel over time during the resting state FMRI scan. A central z-value of 0 means that there is no association between the seed region and the voxel.
Positive and negative z-values approaching 0 reflect increasingly weaker associations, and more extreme positive and negative values reflect stronger associations. Attributing the qualitative labels better or worse to these values depend upon the brain network and context. In many networks (eg, task-positive cognitive control network), a stronger positive correlation is thought to reflect better network organization. In the task-negative default mode network a stronger positive relationship is considered by some as worse. For this study, these are not yet used as clinical measures and there are not known cutoffs.
Measured: Baseline and 1 week
Working Memory - Between Groups at Baseline by Lapsed Category
fMRI working memory differences between participants who lapse back to opioid use and those who don't
Measured: Baseline
Changes in Working Memory - Within Groups During Satiation and Withdrawal
fMRI working memory differences under satiation vs withdrawal from opioids
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2020
- Study completionFeb 2020
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 AddictionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696096
- Sponsor's protocol ID
- 793387
- Status last verified
- Jul 2022
- First submitted
- 9 Feb 2016
- Last updated
- 17 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
- ClinicalTrials.gov ID
- NCT02696096
- Acronym / sponsor ID
- 793387
- Conditions
- Opioid Addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 17 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter.
Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Other: FMRI, Drug: SuboxoneFMRI Suboxone |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- opiate dependent persons
- 21-50 years old
- interested in initiating outpatient buprenorphine treatment
Key exclusion criteria (13 listed)
- current methadone maintenance treatment program participation
- medically necessary prescription opiate treatment (e.g., for chronic pain)
- current criteria for a DSM-V diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
- diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder
- current suicidality on the Modified Scale for Suicidal Ideation
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 |
|---|---|---|
| FMRIAlso: functional magnetic resonance imagingall participants will complete 2 FMRIs | Other | All Participants |
| SuboxoneAlso: buprenorphineall participants will be prescribed Suboxone for 4 months during their study participation | Drug | All Participants |
Primary outcome
Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
Time frame: Baseline and 1 week
The measure of resting state organization is a z-value derived from Pearson's r-values. They represent the effect of the association between the brain activity of the seed region and each brain voxel over time during the resting state FMRI scan. A central z-value of 0 means that there is no association between the seed region and the voxel. Positive and negative z-values approaching 0 reflect increasingly weaker associations, and more extreme positive and negative values reflect stronger associations. Attributing the qualitative labels better or worse to these values depend upon the brain network and context. In many networks (eg, task-positive cognitive control network), a stronger positive correlation is thought to reflect better network organization. In the task-negative default mode network a stronger positive relationship is considered by some as worse. For this study, these are not yet used as clinical measures and there are not known cutoffs.
Working Memory - Between Groups at Baseline by Lapsed Category
Time frame: Baseline
fMRI working memory differences between participants who lapse back to opioid use and those who don't
Changes in Working Memory - Within Groups During Satiation and Withdrawal
Time frame: Baseline and 1 week
fMRI working memory differences under satiation vs withdrawal from opioids
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FMRI and Suboxone in people with Opioid Addiction, run by Butler Hospital 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 13 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: finished, as of the sponsor's last update on 17 Aug 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2022). 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?
Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category (time frame: Baseline and 1 week). The study lists 3 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 17 Aug 2022.