Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

NCT03804619 | Withdrawn FDA Device

• 1 other identifier: 48431
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Dependence; Suicidal Ideation; Depression; Opioid Use; Opioid-Related Disorders; Opioid-use Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Beck Scale for Suicidal Ideation (SSI) score

  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 Outcomes (5)

• Change in Columbia Suicide Severity Scale (C-SSRS) score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Obsessive compulsive drug-use scale (OCDUS) score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Montgomery Asberg Depression Rating Scale (MADRS) score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Beck Depression Inventory II (BDI-II) score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in resting-state functional connectivity.

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

Study Arms (2)

Left DLPFC aiTBS stimulation

EXPERIMENTAL

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)

ACC aiTBS stimulation

EXPERIMENTAL

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)

Interventions

Accelerated intermittent theta-burst stimulation (aiTBS) DEVICE

aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)

ACC aiTBS stimulation; Left DLPFC aiTBS stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Suicidal Ideation; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Study Officials

• Gregory Sahlem, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

Model Details: Open label, two-site randomized trial

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 1, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)