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Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02696096
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Opioid Addiction Other: FMRI Drug: Suboxone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Study Start Date : August 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
All Participants
FMRI Suboxone
Other: FMRI
all participants will complete 2 FMRIs
Other Name: functional magnetic resonance imaging

Drug: Suboxone
all participants will be prescribed Suboxone for 4 months during their study participation
Other Name: buprenorphine

Primary Outcome Measures :
  1. length of time to use opioid after buprenorphine initiated [ Time Frame: 4 months ]
  2. length of time to return to opioid use after buprenorphine initiated [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02696096

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Contact: Michael Stein, MD

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United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Michael Stein, MD    401-455-6646   
Principal Investigator: Michael Stein, MD         
Sponsors and Collaborators
Butler Hospital

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Responsible Party: Michael Stein, MD, Principle Investigator, Butler Hospital Identifier: NCT02696096     History of Changes
Other Study ID Numbers: 793387
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists