42 Participants Needed

iTBS for Alcoholism

ED
Overseen ByErin Deneke, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nicholas Balderston, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
I am diagnosed with AUD and will be in residential treatment for at least 28 days.
See 4 more

Exclusion Criteria

I am not pregnant, planning to become pregnant, breastfeeding, and I am willing to use contraception.
I have undergone TMS therapy before.
Left-handed
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intermittent theta-burst stimulation (iTBS) or sham treatment for 5 days, with 4 sessions per day

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cue reactivity, risk-taking, and impulsiveness

4 months

What Are the Treatments Tested in This Trial?

Interventions

  • iTBS
Trial Overview The study tests if intermittent theta-burst (iTBS) can change behavior and reduce relapse risk in AUD patients compared to usual treatments. It involves exposing participants to alcohol cues while receiving iTBS or sham treatments targeting the prefrontal cortex, measured by brain response.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
Group II: Sham iTBSPlacebo Group1 Intervention

iTBS is already approved in United States for the following indications:

🇺🇸
Approved in United States as iTBS for:

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Who Is Running the Clinical Trial?

Nicholas Balderston, PhD

Lead Sponsor

Trials
2
Recruited
240+

Published Research Related to This Trial

In a study of 26 patients with bipolar depression, active intermittent theta burst stimulation (iTBS) showed a high response rate of 72% and a remission rate of 42%, indicating its potential efficacy in treating this condition.
No adverse events were reported, demonstrating that iTBS is safe and well-tolerated, but further research with larger sample sizes is needed to confirm its superiority over sham treatment.
Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study.Bulteau, S., Beynel, L., Marendaz, C., et al.[2020]
Intermittent theta burst stimulation (iTBS) was found to be safe for veterans with PTSD, even those with mild alcohol use disorder (AUD), although AUD patients reported more adverse events.
Patients with comorbid AUD who received active iTBS showed greater improvement in depression symptoms compared to those without AUD, while the presence of AUD did not affect changes in PTSD symptoms.
Intermittent Theta Burst Stimulation in Veterans with Mild Alcohol Use Disorder.Bozzay, ML., Brigido, S., van 't Wout-Frank, M., et al.[2022]
Intermittent theta-burst stimulation (iTBS) significantly improves hand function in stroke patients, particularly in those with higher baseline motor function and the presence of motor-evoked potentials (MEPs).
The study of 72 stroke patients showed that those with MEPs and better grip strength (Group A) had the greatest improvement in motor function, suggesting that iTBS effectiveness can be predicted by these factors, allowing for more tailored neurostimulation strategies.
Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study.Lai, CJ., Wang, CP., Tsai, PY., et al.[2016]

Citations

The Effect of Intermittent Theta Burst Stimulation (iTBS) in ...This study is a randomized controlled trial to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with sham ...
Theta Burst Stimulation as a tool to decrease drinking ... - TrialsThe present study was designed as a superiority trial to compare the efficacy of two evidence-based cortical target sites in individuals with ...
Intermittent Theta Burst for the Treatment of Alcohol Use ...iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of ...
Intermittent Theta Burst Stimulation in Veterans with Mild ...Overall, iTBS was safe as delivered, and PTSD symptom trajectories appeared to be orthogonal to AUD diagnosis, in that both groups showed ...
Effects of intermittent theta burst to the left dorsolateral ...Participants in this report were in RCTs evaluating the efficacy of iTBS for the treatment of AUD. Across studies, 21 participants were ...
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