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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

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE March 2, 2016
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
  • length of time to use opioid after buprenorphine initiated [ Time Frame: 4 months ]
  • length of time to return to opioid use after buprenorphine initiated [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02696096 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Official Title  ICMJE Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Opioid Addiction
Intervention  ICMJE
  • 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
Study Arms  ICMJE All Participants
FMRI Suboxone
  • Other: FMRI
  • Drug: Suboxone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Stein, MD
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02696096
Other Study ID Numbers  ICMJE 793387
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Stein, MD, Butler Hospital
Study Sponsor  ICMJE Butler Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Butler Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP