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OpenTrials
Completed

NCT Number: NCT02696096

Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

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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Key information

Conditions

Opioid Addiction Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fMRI

Other

all participants will complete 2 FMRIs

Other names: functional magnetic resonance imaging

Suboxone

Drug

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

Other names: buprenorphine

Primary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2016
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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