Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

Stanford University

Status: Withdrawn

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

Treatments: Device: Accelerated intermittent theta-burst stimulation (aiTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03804619

48431

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Left DLPFC aiTBS stimulation

Experimental group

Description:

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.

Treatment:

Device: Accelerated intermittent theta-burst stimulation (aiTBS)

ACC aiTBS stimulation

Experimental group

Description:

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.

Treatment:

Device: Accelerated intermittent theta-burst stimulation (aiTBS)