Back to resultsNeuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Primary Purpose
Opioid Addiction
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FMRI
Suboxone
Sponsored by
About this trial
This is an interventional other trial for Opioid Addiction
Eligibility Criteria
Inclusion Criteria:
- opiate dependent persons
- 21-50 years old
- interested in initiating outpatient buprenorphine treatment
Exclusion Criteria:
- 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•
- 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)
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Participants
Arm Description
FMRI Suboxone
Outcomes
Primary Outcome Measures
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.
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
Changes in Working Memory - Within Groups During Satiation and Withdrawal
fMRI working memory differences under satiation vs withdrawal from opioids
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02696096
Brief Title
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Official Title
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
4. Oversight
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Addiction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Other
Arm Description
FMRI Suboxone
Intervention Type
Other
Intervention Name(s)
FMRI
Other Intervention Name(s)
functional magnetic resonance imaging
Intervention Description
all participants will complete 2 FMRIs
Intervention Type
Drug
Intervention Name(s)
Suboxone
Other Intervention Name(s)
buprenorphine
Intervention Description
all participants will be prescribed Suboxone for 4 months during their study participation
Primary Outcome Measure Information:
Title
Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
Description
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.
Time Frame
Baseline and 1 week
Title
Working Memory - Between Groups at Baseline by Lapsed Category
Description
fMRI working memory differences between participants who lapse back to opioid use and those who don't
Time Frame
Baseline
Title
Changes in Working Memory - Within Groups During Satiation and Withdrawal
Description
fMRI working memory differences under satiation vs withdrawal from opioids
Time Frame
Baseline and 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
opiate dependent persons
21-50 years old
interested in initiating outpatient buprenorphine treatment
Exclusion Criteria:
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•
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)
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
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Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
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