Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

Depression Clinical Trial

Official title:

Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804619
• Other study ID #: 48431
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Brendan Wong
• Phone: 650-374-0907
• Email: bwong14[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Accelerated intermittent theta-burst stimulation (aiTBS)
aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Columbia Suicide Severity Scale (C-SSRS) score	Self-report measure for suicidal ideation	After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary	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.	After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary	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.	After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary	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.	After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary	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.	After all stimulation sessions have been completed (approximately 48 hours after the final session)