Trial Outcomes & Findings for Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence (NCT NCT02696096)
NCT ID: NCT02696096
Last Updated: 2022-08-17
Results Overview
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.
COMPLETED
PHASE3
21 participants
Baseline and 1 week
2022-08-17
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
Opioid Abstinence During Study Period
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11
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
ruled out at screening
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1
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Overall Study
did not attend second fMRI
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1
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Baseline Characteristics
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Baseline characteristics by cohort
| Measure |
All Participants
n=19 Participants
FMRI Suboxone
FMRI: all participants will complete 2 FMRIs
Suboxone: all participants will be prescribed Suboxone for 4 months during their study participation
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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19 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Age, Continuous
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36.63 years
STANDARD_DEVIATION 7.05 • n=99 Participants
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Sex: Female, Male
Female
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7 Participants
n=99 Participants
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Sex: Female, Male
Male
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12 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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16 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=99 Participants
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Race (NIH/OMB)
White
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14 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=99 Participants
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Region of Enrollment
United States
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19 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: Mean fMRI resting state disorganization at baseline among no-lapse and lapse groups
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.
Outcome measures
| Measure |
No Lapse
n=6 Participants
No opioid use during the study period
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Lapse
n=5 Participants
Opioid use during the study period
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|---|---|---|
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Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
DMN synchrony active use
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0.315 Mean default mode network (DMN) z-scores
Standard Deviation 0.057
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0.328 Mean default mode network (DMN) z-scores
Standard Deviation 0.076
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Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
DMN synchrony abstinent
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0.384 Mean default mode network (DMN) z-scores
Standard Deviation 0.098
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0.394 Mean default mode network (DMN) z-scores
Standard Deviation 0.139
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PRIMARY outcome
Timeframe: BaselinePopulation: Mean fMRI working memory response at baseline among no-lapse and lapse groups
fMRI working memory differences between participants who lapse back to opioid use and those who don't
Outcome measures
| Measure |
No Lapse
n=9 Participants
No opioid use during the study period
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Lapse
n=7 Participants
Opioid use during the study period
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|---|---|---|
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Working Memory - Between Groups at Baseline by Lapsed Category
bilateral SMA
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0.45 % fMRI signal change
Standard Deviation 0.14
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0.42 % fMRI signal change
Standard Deviation 0.27
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Working Memory - Between Groups at Baseline by Lapsed Category
R middle frontal gyrus
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0.39 % fMRI signal change
Standard Deviation 0.15
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0.40 % fMRI signal change
Standard Deviation 0.23
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Working Memory - Between Groups at Baseline by Lapsed Category
R inferior parietal lobule
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0.34 % fMRI signal change
Standard Deviation 0.14
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0.33 % fMRI signal change
Standard Deviation 0.24
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Working Memory - Between Groups at Baseline by Lapsed Category
L inferior parietal lobule
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0.36 % fMRI signal change
Standard Deviation 0.14
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0.32 % fMRI signal change
Standard Deviation 0.25
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Working Memory - Between Groups at Baseline by Lapsed Category
L middle frontal gyrus (a)
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0.46 % fMRI signal change
Standard Deviation 0.20
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0.49 % fMRI signal change
Standard Deviation 0.26
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Working Memory - Between Groups at Baseline by Lapsed Category
L middle frontal gyrus (b)
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0.36 % fMRI signal change
Standard Deviation 0.16
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0.33 % fMRI signal change
Standard Deviation 0.25
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Working Memory - Between Groups at Baseline by Lapsed Category
L middle frontal gyrus (c)
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0.39 % fMRI signal change
Standard Deviation 0.22
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0.36 % fMRI signal change
Standard Deviation 0.28
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Working Memory - Between Groups at Baseline by Lapsed Category
bilateral precuneus
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0.38 % fMRI signal change
Standard Deviation 0.20
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0.37 % fMRI signal change
Standard Deviation 0.26
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Working Memory - Between Groups at Baseline by Lapsed Category
R anterior insula
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0.42 % fMRI signal change
Standard Deviation 0.14
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0.39 % fMRI signal change
Standard Deviation 0.26
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PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: Within-group analyses contrasting two fMRI responses
fMRI working memory differences under satiation vs withdrawal from opioids
Outcome measures
| Measure |
No Lapse
n=12 Participants
No opioid use during the study period
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Lapse
n=12 Participants
Opioid use during the study period
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|---|---|---|
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Changes in Working Memory - Within Groups During Satiation and Withdrawal
Mean Brain Response in R middle frontal gyrus
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0.35 % fMRI signal change
Standard Deviation 0.30
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0.37 % fMRI signal change
Standard Deviation 0.25
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Changes in Working Memory - Within Groups During Satiation and Withdrawal
Mean Brain Response in R inferior parietal lobule
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0.33 % fMRI signal change
Standard Deviation 0.29
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0.42 % fMRI signal change
Standard Deviation 0.22
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Changes in Working Memory - Within Groups During Satiation and Withdrawal
Mean Brain Response in L inferior parietal lobule
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0.47 % fMRI signal change
Standard Deviation 0.43
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0.54 % fMRI signal change
Standard Deviation 0.32
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Changes in Working Memory - Within Groups During Satiation and Withdrawal
Mean Brain Response in bilateral supplementary motor
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0.34 % fMRI signal change
Standard Deviation 0.27
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0.35 % fMRI signal change
Standard Deviation 0.22
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Adverse Events
No Lapse
Lapse
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