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Opiate DependenceNCT03804619

Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

A study testing Accelerated intermittent theta-burst stimulation (aiTBS) in people with Opiate Dependence and Suicidal Ideation, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opiate Dependence, Suicidal Ideation, Depression
What is being tested?
Accelerated intermittent theta-burst stimulation (aiTBS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2024to 11 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

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 the 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 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.

Being tested
Accelerated intermittent theta-burst stimulation (aiTBS)
Medical subject headings
Opioid-Related Disorders, Suicidal Ideation, Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT03804619
Study groupRoleWhat they receive
Left DLPFC aiTBS stimulationExperimentalParticipants 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.
Receives: Device: Accelerated intermittent theta-burst stimulation (aiTBS)
ACC aiTBS stimulationExperimentalParticipants 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.
Receives: Device: Accelerated intermittent theta-burst stimulation (aiTBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

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

    Self-report measure for suicidal ideation

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

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

    Self-report measure of drug craving. This questionnaire will be adapted to make it specific for opiate use.

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

  3. Change in Montgomery Asberg Depression Rating Scale (MADRS) score

    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.

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

  4. Change in Beck Depression Inventory II (BDI-II) score

    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.

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

  5. Change in resting-state functional connectivity.

    Resting-state fMRI scans will be conducted before and after the course of aiTBS to examine changes in resting-state functional connectivity.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start1 Jan 2024
  3. Primary completion11 Jul 2024
  4. Study completion11 Jul 2024

Why it stopped: No participants enrolled. No longer continuing study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label, two-site randomized trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804619
Sponsor's protocol ID
48431
Status last verified
Jul 2024
First submitted
11 Jan 2019
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Accelerated intermittent theta-burst stimulation (aiTBS) in people with Opiate Dependence and Suicidal Ideation, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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Clinical Trial NCT03804619 | AzTrials