Status:
WITHDRAWN
Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder
Lead Sponsor:
Stanford University
Conditions:
Opiate Dependence
Suicidal Ideation
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
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 u...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03804619
Start Date
January 1 2024
End Date
July 11 2024
Last Update
July 16 2024
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304