Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

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Butler Hospital

Status and phase

Completed
Phase 3

Conditions

Opioid Addiction

Treatments

Other: FMRI
Drug: Suboxone

Study type

Interventional

Funder types

Other

Identifiers

NCT02696096
793387

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

All Participants
Other group
Description:
FMRI Suboxone
Treatment:
Drug: Suboxone
Other: FMRI

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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