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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Other | FMRI Suboxone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMRI | Other | all participants will complete 2 FMRIs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline |
| Changes in Working Memory - Within Groups During Satiation and Withdrawal | fMRI working memory differences under satiation vs withdrawal from opioids | Baseline and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Who Used Illicit Opioids and Were Interested in Transitioning to Buprenorphine | All participants completed 2 fMRI's and induction on Buprenorphine during the baseline enrollment. Participants were provided Buprenorphine and completed assessments for 4 months. Opioid abstinence was monitored through self-report and urine toxicology during the study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants were using illicit opioids and seeking Buprenorphine treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | FMRI Suboxone FMRI: all participants will complete 2 FMRIs Suboxone: all participants will be prescribed Suboxone for 4 months during their study participation |
| 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 | 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. | Mean fMRI resting state disorganization at baseline among no-lapse and lapse groups | Posted | Mean | Standard Deviation | Mean default mode network (DMN) z-scores | Baseline and 1 week |
4 months
Adverse events were as noted in clinicaltrials.gov
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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 | No Lapse | No opioid use during the study period | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Stein | Butler Hospital | 401-455-6652 | michael_stein@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2017 | May 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2017 | May 11, 2022 | SAP_001.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 |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Suboxone | Drug | all participants will be prescribed Suboxone for 4 months during their study participation |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | No Lapse | No opioid use during the study period |
| OG001 | Lapse | Opioid use during the study period |
|
|
| Primary | 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 | Mean fMRI working memory response at baseline among no-lapse and lapse groups | Posted | Mean | Standard Deviation | % fMRI signal change | Baseline |
|
|
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| Primary | Changes in Working Memory - Within Groups During Satiation and Withdrawal | fMRI working memory differences under satiation vs withdrawal from opioids | Within-group analyses contrasting two fMRI responses | Posted | Mean | Standard Deviation | % fMRI signal change | Baseline and 1 week |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Lapse | Opioid use during the study period | 0 | 7 | 0 | 7 | 0 | 7 |
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| D009270 |
| Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| R inferior parietal lobule |
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| L inferior parietal lobule |
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| L middle frontal gyrus (a) |
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| L middle frontal gyrus (b) |
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| L middle frontal gyrus (c) |
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| bilateral precuneus |
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| R anterior insula |
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| Mean Brain Response in L inferior parietal lobule |
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| Mean Brain Response in bilateral supplementary motor |
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