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Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

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ClinicalTrials.gov Identifier: NCT03804619
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nolan R, Stanford University

Brief Summary:
This study aims to examine whether multiple spaced sessions of intermittent theta-burst transcranial magnetic stimulation (iTBS) induce anti-depressant responses and reduce opiate cravings in adults with opiate use disorder (OUD). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.

Condition or disease Intervention/treatment Phase
Opiate Dependence Suicidal Ideation Depression Opioid Use Opioid-Related Disorders Opioid-use Disorder Major Depressive Disorder Device: Accelerated intermittent theta-burst stimulation (aiTBS) Not Applicable

Detailed Description:
The proposed study aims to investigate the effectiveness of aiTBS applied to either the L-DLPFC or the ACC for reducing SI in individuals with OUD and identify neural functional connectivity changes underlying treatment response. 30 individuals with OUD who endorse suicidal ideation will be recruited. The accelerated iTBS treatment will involve 10 daily sessions of iTBS. Stimulation will be delivered to either the ACC or the L-DLPFC for 5 consecutive days. Suicidal ideation, depressive symptoms and opiate misuse will be measured before and after the 5-day stimulation course. Functional magnetic resonance imaging (fMRI) scans will also be carried out before and after stimulation to examine aiTBS-induced changes in neural functional connectivity. Changes in suicidal ideation, depressive symptoms and opiate misuse will be measured using both clinician-rated and self-report assessments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, two-site randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Left DLPFC aiTBS stimulation
Participants will receive aiTBS (intermittent theta burst stimulation) to a brain area called the left dorsolateral prefrontal cortex (L-DLPFC). Stimulation intensity will be individualized according to the individual's resting motor threshold.
Device: Accelerated intermittent theta-burst stimulation (aiTBS)
aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)

Experimental: ACC aiTBS stimulation
Participants will receive aiTBS (intermittent theta burst stimulation) to a brain area called the anterior cingulate cortex (ACC). Stimulation intensity will be individualized according to the individual's resting motor threshold.
Device: Accelerated intermittent theta-burst stimulation (aiTBS)
aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)




Primary Outcome Measures :
  1. Change in Beck Scale for Suicidal Ideation (SSI) score [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults. Scores range from 0-38.


Secondary Outcome Measures :
  1. Change in Columbia Suicide Severity Scale (C-SSRS) score [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    Self-report measure for suicidal ideation

  2. Change in Obsessive compulsive drug-use scale (OCDUS) score [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    Self-report measure of drug craving. This questionnaire will be adapted to make it specific for opiate use.

  3. Change in Montgomery Asberg Depression Rating Scale (MADRS) score [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60.

  4. Change in Beck Depression Inventory II (BDI-II) score [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

  5. Change in resting-state functional connectivity. [ Time Frame: After all stimulation sessions have been completed (approximately 48 hours after the final session) ]
    Resting-state fMRI scans will be conducted before and after the course of aiTBS to examine changes in resting-state functional connectivity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over 18 at the time of screening
  2. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
  3. Diagnosed with Opiate Use Disorder, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders.
  4. Endorse suicidal ideation (score >2 on the SSI-C).
  5. Not in a current state of mania or psychosis (Young Mania Rating Scale)
  6. In good general health, as ascertained by medical history.
  7. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:, a. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or, b. Childbearing potential, and meets the following criteria. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent. ii. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at randomization prior to receiving study treatment. iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline.
  8. Clear urine drugs test
  9. Registered with a psychiatrist
  10. On stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
  11. Failed at least one anti-depressant trial (>/=6 week duration at an effective dose)
  12. Ability to tolerate clinical study procedures.
  13. No contraindications for TMS or MRI

Exclusion Criteria:

  1. Any abnormalities indicated on the MRI e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
  2. Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
  3. History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
  4. Shrapnel or any ferromagnetic item in the head.
  5. Pregnancy
  6. Autism Spectrum disorder
  7. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
  8. Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
  9. Cognitive impairment (including dementia)
  10. Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
  11. Current mania
  12. Current unmanageable psychosis
  13. Showing symptoms of withdrawal from alcohol or benzodiazepines
  14. IQ<70
  15. Movement disorder
  16. Any other indication the PI feels would comprise data.
  17. Motor threshold value which does not enable treatment

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): NCT03804619


Contacts
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Contact: Eleanor J Cole, PhD 4157247960 ecole@stanford.edu
Contact: Romina Nejad, MS 650-497-3933 rnejad@stanford.edu

Locations
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United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Eleanor J Cole, PhD    415-724-7960    ecole@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Nolan R Williams, MD Stanford University

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Responsible Party: Nolan R, Instructor of Psychiatry & Behavioral Sciences, Director of the Brain Stimulation Laboratory at Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03804619     History of Changes
Other Study ID Numbers: 48431
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Suicidal Ideation
Pathologic Processes
Behavioral Symptoms
Suicide
Self-Injurious Behavior
Opiate Alkaloids
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents