Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

Trial details

Who runs it

Stanford University

Trial code

NCT03804619

Record updated

16 July 2024

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear; History of epilepsy/ seizures (including history of withdrawal/ provoked seizures); 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; Cognitive impairment (including dementia); Movement disorder; 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; Shrapnel or any ferromagnetic item in the head; Pregnancy; Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines; 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; Any other indication the PI feels would comprise data; Motor threshold value which does not enable treatment.

ClinicalTrials.gov NCT03804619