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rTMS for Opioid Use Disorder (TOTS Trial)

N/A
Recruiting
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and non-pregnant/non-lactating females
Age 21-70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively)
Awards & highlights

TOTS Trial Summary

This trial is studying whether a certain brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) can help people with opioid use disorder who are starting methadone treatment.

Who is the study for?
This trial is for adults aged 21-70 with opioid use disorder who are currently in methadone or buprenorphine treatment, right-handed, and have an IQ score over 80. They should not be heavy users of alcohol or marijuana. People with certain mental health disorders, recent use of other illicit drugs, or medical conditions that rTMS isn't safe for cannot join.Check my eligibility
What is being tested?
The study tests if repetitive transcranial magnetic stimulation (rTMS) can help people with opioid addiction by targeting brain areas linked to substance use and cognitive functions like decision-making and emotional control. Participants will receive rTMS while undergoing standard methadone treatment.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. It's generally considered safe but might not be suitable for everyone due to these potential side effects.

TOTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male or a female not currently pregnant or breastfeeding.
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I am between 21 and 70 years old.
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My cognitive abilities are intact.

TOTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emotional Arousal task rating
Opioid progressive ratio breakpoint
Treatment success
+1 more
Secondary outcome measures
Digit Span total score
Monetary delay discounting
Positive and Negative Affect Scale total score
+1 more

TOTS Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Active 10 Hz dlPFC rTMSExperimental Treatment1 Intervention
10 Hz dorsolateral prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)
Group II: Active 1 Hz mPFC rTMSExperimental Treatment1 Intervention
1 Hz medial prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)
Group III: Sham dlPFC rTMSPlacebo Group1 Intervention
inactive dorsolateral prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)
Group IV: Sham mPFCPlacebo Group1 Intervention
inactive medial prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,747 Total Patients Enrolled
Mark K Greenwald, PhDStudy DirectorWayne State University
5 Previous Clinical Trials
252 Total Patients Enrolled

Media Library

rTMS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04920864 — N/A
Opioid Use Disorder Research Study Groups: Active 10 Hz dlPFC rTMS, Sham dlPFC rTMS, Active 1 Hz mPFC rTMS, Sham mPFC
Opioid Use Disorder Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT04920864 — N/A
rTMS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04920864 — N/A

Frequently Asked Questions

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

Could I have the opportunity to join this medical trial?

"This medical trial requires enrollees to be between 21 and 60 years old, with a diagnosis of opioid use disorder (OUD). The maximum capacity for this study is 32 individuals."

Answered by AI

How many participants are currently receiving treatment under this clinical trial?

"Yes, according to clinicaltrials.gov the trial is actively seeking participants. This study was initially posted on April 1st 2022 and subsequently revised on April 26th 2022 with a goal of recruiting 32 patients from one location."

Answered by AI

What aims are researchers seeking to accomplish with this trial?

"The main metric of this experiment, which involves a sham-to-active condition transition (scheduled between days 6 and 12, alongside 18 to 24), is the Wisconsin Card Sorting Task perseverance score. Secondary objectives include measuring State Anxiety subscale scores from the State-Trait Anxiety Inventory with lower numbers implying better outcomes, Positive and Negative Affect Scale total score with lesser amounts of negative affect representing improved results, as well as Monetary delay discounting where higher area under curve figures (preferring delayed money) point towards superior performance."

Answered by AI

Is there still time to enroll in this medical experiment?

"As per the information presented on clinicaltrials.gov, this trial is actively searching for participants to join. It was posted online April 1st 2022 and modified most recently on April 26th of the same year."

Answered by AI

Is this medical research open to seniors above the age of seventy?

"To fulfil the entrance requirements for this study, applicants must be between 21 and 60 years old. Additionally, there are 89 clinical trials specifically designed to accommodate people under 18 while 400 other studies exist aimed at those over 65."

Answered by AI
~1 spots leftby May 2024