Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

Opioid Addiction Clinical Trial

Official title:

Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696096
• Other study ID #: 793387
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: February 2020

Study information

• Verified date: July 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Addiction
• Opioid-Related Disorders

Intervention

Other:
• FMRI
all participants will complete 2 FMRIs

Drug:
• Suboxone
all participants will be prescribed Suboxone for 4 months during their study participation

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 1 week
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	Baseline
Primary	Changes in Working Memory - Within Groups During Satiation and Withdrawal	fMRI working memory differences under satiation vs withdrawal from opioids	Baseline and 1 week