tDCS to Decrease Opioid Relapse
Primary Purpose
Opioid Dependence, Craving
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility 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)
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
tDCS
sham tDCS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
changes in opioid craving
Visual Analog Craving scale (scoring: 1 - 10, with 1 = no craving and 10 = extreme craving; lower scores = less craving and higher scores = more craving)
change in the saliency network
activity in any node of the proposed network
change in the cognitive control network
activity in any node of the proposed network
change in EEG oscillatory targets
frontal theta power during working memory
lower rates of opioid relapse
Timeline follow-back interview
Secondary Outcome Measures
Full Information
NCT ID
NCT03842137
First Posted
February 13, 2019
Last Updated
October 23, 2023
Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03842137
Brief Title
tDCS to Decrease Opioid Relapse
Official Title
tDCS to Decrease Opioid Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in opioid craving
Description
Visual Analog Craving scale (scoring: 1 - 10, with 1 = no craving and 10 = extreme craving; lower scores = less craving and higher scores = more craving)
Time Frame
2 week
Title
change in the saliency network
Description
activity in any node of the proposed network
Time Frame
2 week
Title
change in the cognitive control network
Description
activity in any node of the proposed network
Time Frame
2 week
Title
change in EEG oscillatory targets
Description
frontal theta power during working memory
Time Frame
2 week
Title
lower rates of opioid relapse
Description
Timeline follow-back interview
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Abrantes, Ph.D.
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael D Stein, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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tDCS to Decrease Opioid Relapse
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