What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) is generally well-tolerated, with common side effects including mild skin irritation at the electrode site, tingling sensations, and headaches. Other common treatments for alcoholism, such as naltrexone, can cause nausea, headache, dizziness, and fatigue. Varenicline and bupropion, used for smoking cessation in patients with alcohol use disorder, may lead to neuropsychiatric symptoms like anxiety, depression, and agitation. Overall, while tDCS has fewer systemic side effects, pharmacotherapies can have a broader range of adverse effects.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for Alcohol Use Disorder (AUD), including disulfiram, naltrexone, and acamprosate. These medications work through different mechanisms to reduce alcohol cravings and support abstinence. While Transcranial Direct Current Stimulation (tDCS) is being studied as a non-invasive neuromodulation technique targeting the dorsolateral prefrontal cortex (DLPFC) to improve executive functioning and support long-term abstinence in AUD, it has not yet received FDA approval for this indication. Current FDA-approved treatments focus primarily on pharmacotherapy rather than neuromodulation.

What other types of research exist?

Promising, novel alternatives to tDCS for treating AUD include Transcranial Magnetic Stimulation (TMS) and Deep Brain Stimulation (DBS). TMS has shown potential in improving executive functioning and reducing relapse rates by targeting the DLPFC. DBS, although more invasive, is being explored for its efficacy in treatment-resistant cases of addiction. Both methods are under continuous research and may offer viable options for patients seeking treatment in 2024.

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Cognitive Training + Brain Stimulation for Alcoholism

N/A

Recruiting

Led By Jazmin Camchong, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Clinical evidence for Wernicke-Korsakoff syndrome

Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness >30 min, HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months post-intervention

Summary

This trial aims to help people with alcohol use disorder by using a gentle electrical brain stimulation combined with mental exercises. The goal is to improve their ability to stay sober for a long time. Researchers will also study how genetic differences affect treatment success.

Who is the study for?

This trial is for individuals with Alcohol Use Disorder (AUD) who are committed to staying in a treatment program and have been abstinent from alcohol. They must meet specific mental health criteria, not have other primary substance use disorders except caffeine or nicotine, and cannot have certain neurological conditions or contraindications for tDCS or MRI.

What is being tested?

The TANGO study tests if combining brain stimulation (tDCS) targeting the DLPFC region with cognitive training can improve executive function and help maintain abstinence in AUD patients. It also explores how genetic profiles might influence treatment response.

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, nausea. Cognitive training is generally safe but could potentially cause temporary mental fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Wernicke-Korsakoff syndrome.

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I have a condition or received treatment that affected my nervous system.

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I have had a head injury with a skull fracture or was unconscious for over 30 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in D-KEFS Color Word score

Change in D-KEFS Trail Making (1-5) score

Change in D-KEFS Verbal Frequency score

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving active transcranial direct current stimulation (tDCS)Experimental Treatment2 Interventions

Participants in this group will receive 5 sessions of active transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex (DLPFC) while in the Lodging Plus treatment program and then 5 remote sessions of active tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

Group II: Participants receiving active and sham active transcranial direct current stimulation (tDCS)Placebo Group2 Interventions

Participants in this group will receive 5 sessions of sham-tDCS sessions while in the Lodging Plus treatment program and then 5 remote sessions of active-tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that targets the dorsolateral prefrontal cortex (DLPFC) to improve executive functioning and support long-term abstinence in patients with Alcohol Use Disorder (AUD). By modulating neural activity in the DLPFC, tDCS enhances cognitive control and decision-making processes, which are often impaired in individuals with AUD. This improvement in executive functioning helps patients resist cravings and reduces the likelihood of relapse. Other common treatments for alcoholism include medications like naltrexone, which blocks opioid receptors to reduce the rewarding effects of alcohol, and acamprosate, which stabilizes brain chemistry to decrease withdrawal symptoms. Behavioral therapies, such as cognitive-behavioral therapy (CBT), focus on changing drinking behaviors and developing coping strategies. Understanding these mechanisms is crucial for tailoring effective treatment plans and improving outcomes for alcoholism patients.