Transcranial Magnetic Stimulation for Alcoholism

Recruiting in Palo Alto (17 mi)

Overseen by Merideth A Addicott, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Must not be taking: Disulfiram, Naltrexone, Acamprosate, Topiramate

Disqualifiers: Psychoactive substance use, Schizoaffective disorder, Suicidal ideation, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.

Will I have to stop taking my current medications?

If you are currently taking medications that affect alcohol intake or craving, like disulfiram, naltrexone, acamprosate, or topiramate, you will need to stop taking them to participate in this trial. The protocol does not specify about other medications, so it's best to discuss your specific situation with the trial coordinators.

What data supports the effectiveness of the treatment Theta Burst Stimulation (TBS) for alcoholism?

Research shows that Theta Burst Stimulation (TBS), a type of transcranial magnetic stimulation, has been effective in reducing cravings for methamphetamine and cocaine, suggesting it might help with alcohol cravings too. TBS is also similar in effectiveness to other forms of brain stimulation used for depression, which supports its potential use for alcohol use disorder.

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Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation, including its variant theta burst stimulation (TBS), has been shown to be generally safe and well-tolerated in studies for various conditions like depression and substance use disorders. Some participants may experience mild side effects like headaches, but serious adverse events are rare.

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How is Theta Burst Stimulation (TBS) different from other treatments for alcoholism?

Theta Burst Stimulation (TBS) is a unique treatment for alcoholism because it uses magnetic pulses to stimulate specific brain areas, is shorter in duration, and potentially more tolerable than traditional repetitive transcranial magnetic stimulation (rTMS). It has shown promise in reducing cravings in addiction disorders, although its full effects on alcohol use disorder are still being studied.

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Eligibility Criteria

This trial is for adults aged 21-75 with Alcohol Use Disorder (AUD), as indicated by an AUDIT score above 8. Participants must meet DSM-V criteria for AUD and cannot be at risk of pregnancy, nursing, or planning a pregnancy without reliable birth control. They should not have suicidal/homicidal thoughts, expect major medical changes soon, use psychoactive substances (except marijuana/nicotine) recently, or be on medications affecting alcohol intake/craving.

Inclusion Criteria

I am between 21 and 75 years old.

You have a score of 8 or higher on the AUDIT (Alcohol Use Disorders Identification Test), which means you are considered a medium or high-risk drinker.

Meets the DSM V criteria for having a current AUD, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V

Exclusion Criteria

I have had a serious brain injury that required hospitalization or caused me to lose consciousness for over 10 minutes.

You have used any drugs that affect your mind or mood, except for marijuana and nicotine, in the past month according to what you have told us.

Does not meet safety criteria for MRI and TMS

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 15 sessions of TMS (2x/day; 3x/week) over 5 weeks, targeting either the VMPFC or DLPFC.

5 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including alcohol consumption and craving.

4 months

3 monthly visits (in-person)

Extension

Optional continuation of monitoring and assessment for long-term outcomes.

Long-term

Participant Groups

The study tests two transcranial magnetic stimulation (TMS) strategies to reduce alcohol consumption in individuals seeking treatment for AUD. It compares the effects of Real TBS versus Sham TBS applied to either the ventromedial prefrontal cortex (vmPFC) or dorsolateral prefrontal cortex (dlPFC) over four months on abstinence and reaction to alcohol cues.

Group I: Real TBS to the mPFC Experimental Treatment 1 Intervention

Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)

Group II: Real TBS to the dlPFC Experimental Treatment 1 Intervention

Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)

Group III: Sham TBS to the mPFC Placebo Group 1 Intervention

Thirty sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)

Group IV: Sham TBS to the dlPFC Placebo Group 1 Intervention

Thirty sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)

Theta Burst Stimulation is already approved in United States for the following indications:

🇺🇸 Approved in United States as Theta Burst Stimulation for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest School of Medicine Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences Lead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder: Study Protocol for a Randomized Controlled Trial. [2022] Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation technique which has a treatment potential for alcohol use disorder. Intermittent theta burst stimulation (iTBS) is a new rTMS technique which is shorter in duration and thus with better tolerability and shows similar efficacy as rTMS for the treatment of depression. The effect of iTBS on reducing craving in alcohol use disorder patients requires further investigation.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. [2020] There are no effective treatments for cocaine use disorder (CUD), a chronic, relapsing brain disease characterized by dysregulated circuits related to cue reactivity, reward processing, response inhibition, and executive control. Transcranial magnetic stimulation (TMS) has the potential to modulate circuits and networks implicated in neuropsychiatric disorders, including addiction. Although acute applications of TMS have reduced craving in urine-negative cocaine users, the tolerability and safety of administering accelerated TMS to cocaine-positive individuals is unknown. As such, we performed a proof-of-concept study employing an intermittent theta-burst stimulation (iTBS) protocol in an actively cocaine-using sample. Although our main goal was to assess the tolerability and safety of administering three iTBS sessions daily, we also hypothesized that iTBS would reduce cocaine use in this non-treatment seeking cohort. We recruited 19 individuals with CUD to receive three open-label iTBS sessions per day, with approximately a 60-min interval between sessions, for 10 days over a 2-week period (30 total iTBS sessions). iTBS was delivered to left dorsolateral prefrontal cortex (dlPFC) with neuronavigation guidance. Compliance and safety were assessed throughout the trial. Cocaine use behavior was assessed before, during, and after the intervention and at 1- and 4-week follow-up visits. Of the 335 iTBS sessions applied, 73% were performed on participants with cocaine-positive urine tests. Nine of the 14 participants who initiated treatment received at least 26 of 30 iTBS sessions and returned for the 4-week follow-up visit. These individuals reduced their weekly cocaine consumption by 78% in amount of dollars spent and 70% in days of use relative to pre-iTBS cocaine use patterns. Similarly, individuals reduced their weekly consumption of nicotine, alcohol, and THC, suggesting iTBS modulated a common circuit across drugs of abuse. iTBS was well-tolerated, despite the expected occasional headaches. A single participant developed a transient neurological event of uncertain etiology on iTBS day 9 and cocaine-induced psychosis 2 weeks after discontinuation. It thus appears that accelerated iTBS to left dlPFC administered in active, chronic cocaine users is both feasible and tolerable in actively using cocaine participants with preliminary indications of efficacy in reducing both the amount and frequency of cocaine (and other off target drug) use. The neural underpinnings of these behavioral changes could help in the future development of effective treatment of CUD.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation in Veterans with Mild Alcohol Use Disorder. [2022] Alcohol use disorder (AUD) is highly comorbid with depression and posttraumatic stress disorder (PTSD) and can complicate their treatment. Transcranial magnetic stimulation is a promising treatment for these disorders, yet prior research often excluded AUD patients out of concern for safety or poorer outcomes. To this end, we revisited a prior study of intermittent theta burst stimulation (iTBS) for PTSD, to evaluate whether mild AUD impacted safety and clinical outcomes.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study. [2020] Transcranial Magnetic Stimulation (TMS) is earning a role in the therapeutic arsenal of cocaine use disorder (CUD). A widespread and still growing number of studies have reported beneficial use of repeated TMS (rTMS) in reduction of craving, intake and cue-induced craving in cocaine addicts. In spite of these encouraging findings, many issues are still unresolved such as brain area to be stimulated, laterality of the effects, coil geometry and stimulation protocols/parameters. Intermittent theta burst stimulation (iTBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols. Yet, its effects on cocaine craving and length of abstinence in comparison with standard high frequency (10-15 Hz) protocols have never been evaluated so far. In the present paper, we describe the effect of the bilateral iTBS of the prefrontal cortex (PFC) in a population (n = 25) of treatment-seeking cocaine addicts, in an outpatient setting, and compare them with 15 Hz stimulation of the same brain area (n = 22). The results indicate that iTBS produces effects on cocaine consumption and cocaine craving virtually superimposable to the 15 Hz rTMS group. Both treatments had low numbers of dropouts and similar side-effects, safety and tolerability profiles. While larger studies are warranted to confirm these observations, iTBS appears to be a valid approach to be considered in treatment-seeking cocaine addicts, especially in light of its brief duration (3 min) vs. 15 Hz stimulation (15 min). The use of iTBS would allow increasing the number of patients treated per day with current rTMS devices, thus reducing patient discomfort and hopefully reducing drop-out rates without compromising clinical effectiveness.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. [2023] Transcranial magnetic stimulation (TMS) holds potential promise as a therapeutic modality for disorders of addiction. Our previous findings indicate that high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsal-lateral prefrontal cortex (DLPFC) and low-frequency rTMS over the right DLPFC can reduce drug craving for methamphetamine. One major issue with rTMS is the duration of treatment and hence potential dropout rate. Theta burst stimulation (TBS) has been recently shown to be non-inferior relative to repetitive transcranial magnetic stimulation for major depression. Here, we aim to compare the clinical efficacy and tolerability of intermittent and continuous theta burst stimulation protocols targeting left or right dorsolateral prefrontal cortex on methamphetamine craving in abstinent-dependent subjects.

6. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. [2019] The aim of this open study was to evaluate the safety and tolerability of theta-burst transcranial magnetic stimulation (TBS) and to assess preliminarily its therapeutic efficacy in patients with major depression. A total of 33 patients were assigned to receive one of four TBS protocols for 10 consecutive work days. TBS consisted of triple-pulse 50-Hz bursts given at a rate of 5 Hz to the left or right dorsolateral prefrontal cortex at different stimulation parameters. Severity of depression was assessed by the Hamilton Depression Rating Scale. Our results indicate that TBS as applied in this study is safe and well tolerated in depressed patients and seems to have antidepressant properties. Increase of stimulation parameters is not associated with more side-effects and adds to its therapeutic effect.

7. United States pubmed.ncbi.nlm.nih.gov

Dose-dependence of changes in cortical protein expression induced with repeated transcranial magnetic theta-burst stimulation in the rat. [2016] Theta Burst stimulation (TBS) applied via transcranial magnetic stimulation (TMS) effectively modulates human neocortical excitability but repeated applications of the same TBS protocol at short intervals may be not simply accumulative.

8. United States pubmed.ncbi.nlm.nih.gov

Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial. [2022] Theta burst pattern repetitive transcranial magnetic stimulation (TBS) is increasingly applied to treat depression. TBS's brevity is well-suited to application in accelerated schedules. Sizeable trials of accelerated TBS are lacking; and optimal TBS parameters such as stimulation intensity are not established.