iTBS for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates whether a new brain stimulation technique, intermittent theta-burst stimulation (iTBS), can assist individuals with alcohol use disorder (AUD) undergoing inpatient treatment. It compares iTBS to a placebo treatment to determine its effectiveness in reducing cravings and risky behaviors, as well as its impact on relapse rates after four months. Eligible participants should be right-handed, diagnosed with AUD, and planning to remain in a residential treatment program at Caron Treatment Centers for at least 28 days. The trial aims to enhance treatment effectiveness and potentially shorten its duration. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve treatment options for AUD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that intermittent theta-burst stimulation (iTBS) is safe for individuals with alcohol use disorder?
Studies have shown that intermittent theta-burst stimulation (iTBS) is generally safe. Research indicates that iTBS shares a safety profile with repetitive transcranial magnetic stimulation (rTMS), a well-known treatment for various conditions. In trials with patients who have alcohol use disorder, iTBS was well-tolerated, with no major safety concerns reported. Another study found that iTBS was safe for veterans with PTSD, suggesting it does not cause significant side effects even in sensitive groups. Overall, evidence suggests that iTBS is safe, with most participants not experiencing serious adverse effects.12345
Why are researchers excited about this trial?
Researchers are excited about iTBS for alcoholism because it offers a novel approach by using brain stimulation. Unlike traditional treatments like counseling, medication, or support groups, iTBS involves brief bursts of magnetic pulses aimed at specific brain areas involved in addiction. This direct brain stimulation could potentially alter brain activity linked to cravings and dependency, providing a quicker, non-invasive method to complement existing therapies. Moreover, iTBS sessions are short, possibly leading to faster improvements compared to conventional treatments which often take weeks to show results.
What evidence suggests that iTBS might be an effective treatment for alcoholism?
Research has shown that intermittent theta-burst stimulation (iTBS) might benefit individuals with alcohol use disorder (AUD). In this trial, participants will receive either active iTBS or a sham iTBS treatment. One study applied active iTBS to a brain region involved in decision-making and impulse control, resulting in reduced alcohol cravings compared to a sham treatment. Another study found iTBS to be as effective and safe as traditional methods used for various conditions. Early results suggest that iTBS could reduce drinking by affecting brain areas linked to addiction. These findings offer hope for using iTBS to lower alcohol consumption and support recovery in individuals with AUD.12345
Are You a Good Fit for This Trial?
This trial is for individuals with alcohol use disorder (AUD) who are currently in inpatient substance use treatment. Participants should be willing to undergo a type of brain stimulation therapy called iTBS or a sham treatment as part of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intermittent theta-burst stimulation (iTBS) or sham treatment for 5 days, with 4 sessions per day
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cue reactivity, risk-taking, and impulsiveness
What Are the Treatments Tested in This Trial?
Interventions
- iTBS
iTBS is already approved in United States for the following indications:
- Treatment-resistant depression
- Major depressive disorder
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Who Is Running the Clinical Trial?
Nicholas Balderston, PhD
Lead Sponsor