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Behavioural Intervention

Theta-Burst Stimulation for Opioid Addiction

N/A
Waitlist Available
Led By Gregory Sahlem, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed at least one anti-depressant trial (>/=6 week duration at an effective dose)
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after all stimulation sessions have been completed (approximately 48 hours after the final session)
Awards & highlights

Study Summary

This trial will test whether a new type of brain stimulation can help people with opiate addiction by reducing cravings and depression.

Who is the study for?
This trial is for adults over 18 with Opioid Use Disorder who are in good health, have a negative drug test, and if female, use effective birth control. They must be registered with a psychiatrist, on stable mental health treatment for 6+ weeks, and have failed at least one antidepressant trial. Excludes those with autism, low IQ, movement disorders, mania or psychosis history, recent substance use other than opioids or intoxication.Check my eligibility
What is being tested?
The study tests whether accelerated intermittent theta-burst stimulation (aiTBS), a non-invasive brain stimulation technique can reduce depression symptoms and opioid cravings in people with Opioid Use Disorder. It also examines changes in brain connectivity related to the effectiveness of aiTBS.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of TMS may include headache or discomfort at the stimulation site; rare risks include seizures or hearing loss without ear protection during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried an antidepressant for 6 weeks or more without success.
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I am either not able to have children or am using effective birth control.
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I am over 18 years old.
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I have been on stable mental health treatment for 6 weeks and plan to continue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after all stimulation sessions have been completed (approximately 48 hours after the final session)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after all stimulation sessions have been completed (approximately 48 hours after the final session) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beck Scale for Suicidal Ideation (SSI) score
Secondary outcome measures
Change in Beck Depression Inventory II (BDI-II) score
Change in Columbia Suicide Severity Scale (C-SSRS) score
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Left DLPFC aiTBS stimulationExperimental Treatment1 Intervention
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.
Group II: ACC aiTBS stimulationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,897 Total Patients Enrolled
Gregory Sahlem, MDPrincipal InvestigatorStanford University
6 Previous Clinical Trials
172 Total Patients Enrolled
Nolan R Williams, MDPrincipal InvestigatorStanford University

Media Library

Accelerated Intermittent Theta-Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03804619 — N/A
Opioid Use Disorder Research Study Groups: ACC aiTBS stimulation, Left DLPFC aiTBS stimulation
Opioid Use Disorder Clinical Trial 2023: Accelerated Intermittent Theta-Burst Stimulation Highlights & Side Effects. Trial Name: NCT03804619 — N/A
Accelerated Intermittent Theta-Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03804619 — N/A
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03804619 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any open slots for participation in this experiment?

"Unfortunately, the data on clinicaltrials.gov indicates that this particular medical trial is no longer seeking enrolment from potential test subjects. This study was initially posted on January 1st of 2023 and last updated on October 24th 2022; however, there are over two-thousand other studies actively recruiting now."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I have been taking opioids for pain and now can't seem to stop. I have had a past drug problem with meth but haven't used since meth since 2003.
PatientReceived 1 prior treatment
I have tried multiple western medicine treatments along with other homeopathic and psychedelic treatments such Ayawaska, Microdosing psilocybin and ketamine to help with my depression, opiate use and suicidal tendencies. Some have helped aid certain symptoms but never all of them equally. One of my symptoms usually come as package deal. Sometimes it starts with the suicidal thoughts and then the continuation of those leads to depression which leads to me self medicating.
PatientReceived 2+ prior treatments
~20 spots leftby Dec 2024