Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 4/17/2018 |
| Start Date: | August 2016 |
| End Date: | April 2020 |
| Contact: | Michael Stein, MD |
| Email: | michael_stein@brown.edu |
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).
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).
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)
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Michael Stein, MD
Phone: 401-455-6646
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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