Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Brendan Wong
- Phone Number: 650-374-0907
- Email: bwong14@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 at the time of screening
- 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.
- Diagnosed with Opiate Use Disorder, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders.
- Endorse suicidal ideation (score >2 on the SSI-C).
- Not in a current state of mania or psychosis (Young Mania Rating Scale)
- In good general health, as ascertained by medical history.
- 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.
- Clear urine drugs test
- Registered with a psychiatrist
- On stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
- Failed at least one anti-depressant trial (>/=6 week duration at an effective dose)
- Ability to tolerate clinical study procedures.
- No contraindications for TMS or MRI
Exclusion Criteria:
- 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.
- Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- Shrapnel or any ferromagnetic item in the head.
- Pregnancy
- Autism Spectrum disorder
- 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.
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- Cognitive impairment (including dementia)
- Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- Current mania
- Current unmanageable psychosis
- Showing symptoms of withdrawal from alcohol or benzodiazepines
- IQ<70
- Movement disorder
- Any other indication the PI feels would comprise data.
- Motor threshold value which does not enable treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
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.
|
aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
|
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.
|
After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
|
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.
|
After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
|
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)
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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.
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After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
|
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.
|
After all stimulation sessions have been completed (approximately 48 hours after the final session)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Gregory Sahlem, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 48431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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