Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Condition: Opioid Addiction
MeSH terms: Opioid-Related Disorders
Intervention: FMRI; Suboxone
Intervention description: all participants will complete 2 FMRIs; all participants will be prescribed Suboxone for 4 months during their study participation
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No

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).
    

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)