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tDCS to Decrease Opioid Relapse

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ClinicalTrials.gov Identifier: NCT03842137
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

Study Description
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Brief Summary:
In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using functional magnetic resonance imaging (FMRI) and electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI and EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC. In phase 2, the investigators will perform a larger randomized clinical trial (RCT) (vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained FMRI changes.

Condition or disease Intervention/treatment Phase
Opioid Dependence Craving Device: tDCS Device: sham tDCS Not Applicable

Detailed Description:

This study has two phases. In phase one (UG3), the investigators propose to use FMRI to quantify changes in brain function and EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed using FMRI and EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. With a focus on the craving outcome, the investigators will use two task-based FMRI paradigms that challenge networks associated with craving (CR) and cognitive control (CCN), and will examine these and the salience network using resting state functional connectivity. In Phase 1, FMRI and EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of greater FMRI change in any node of the CR or CCN networks or enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving measured during a cue reactivity task or outside the FMRI following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.

In phase 2, the investigators will perform a larger RCT using the same treatment protocol in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Phase two will address long-term (3-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained fMRI changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 12 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on >4 days per month and having an opioid positive urine screen), as well as days of opioid use.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tDCS to Decrease Opioid Relapse
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
 Device: tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
Sham Comparator: sham tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
 Device: sham tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.


Outcome Measures
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Primary Outcome Measures :
  1. changes in opioid craving [ Time Frame: 2 week ]
    Visual Analog Craving scale (scoring: 1 - 10, with 1 = no craving and 10 = extreme craving; lower scores = less craving and higher scores = more craving)

  2. change in the saliency network [ Time Frame: 2 week ]
    activity in any node of the proposed network

  3. change in the cognitive control network [ Time Frame: 2 week ]
    activity in any node of the proposed network

  4. change in EEG oscillatory targets [ Time Frame: 2 week ]
    frontal theta power during working memory

  5. lower rates of opioid relapse [ Time Frame: 3 month ]
    Timeline follow-back interview


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

Inclusion Criteria:

  • current opioid dependence
  • between 21-50 years of age
  • recent initiation of buprenorphine or methadone (<30 days)

Exclusion Criteria:

  • current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
  • current suicidality
  • evidence of neurocognitive dysfunction
  • contraindications for tDCS (e.g seizure disorder)
  • probation/parole requirements or an upcoming move that might interfere with protocol participation
  • planning to terminate buprenorphine in less than 3 months
  • scalp lesions near the tDCS electrode sites

Exclusion Criteria related to FMRI scanning are:

  • history of neurological disorder (e.g., epilepsy, stroke, brain injury with loss of consciousness>10 min)
  • impaired uncorrected vision
  • MRI contraindications (e.g., claustrophobia, specific metallic implants and injuries, and pregnancy)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03842137


Contacts
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Contact: Ana M Abrantes, Ph.D. 401-455-6440 Ana_Abrantes@Brown.edu
Contact: Julie Desaulniers, M.S. 401-455-6219 jdesaulniers@butler.org

Locations
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United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Ana M Abrantes, Ph.D.    401-455-6440    Ana_Abrantes@Brown.edu   
Principal Investigator: Ana M. Abrantes, Ph.D.         
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ana M Abrantes, Ph.D. Butler Hospital
Principal Investigator: Michael D Stein, M.D. Boston University
More Information
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT03842137    
Other Study ID Numbers: 1810-001
UG3DA047793 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders