Brain Stimulation + Psychotherapy for Alcoholism

(tACS-MI Trial)

Overseen By Jon M Houck, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: The Mind Research Network

Disqualifiers: Brain injury, Psychosis, Severe withdrawal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 session

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether brain stimulation, specifically high-density transcranial alternating current stimulation, can enhance the effects of motivational interviewing, a type of counseling, to reduce risky drinking habits. Participants will be divided into three groups: one receiving active brain stimulation, one receiving sham stimulation, and a control group with no initial stimulation. The study will track changes in drinking habits, brain activity, and emotions. Ideal participants are right-handed individuals who recognize a drinking problem and are not currently in treatment.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative approaches in reducing risky drinking habits.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving treatment for alcohol use disorder, you are not eligible to participate.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments in this study, transcranial alternating current stimulation (tACS) and motivational interviewing (MI), are generally safe. Previous studies found that tACS is usually well-tolerated, with no serious side effects reported. Rarely, some individuals might experience minor skin issues. MI, a counseling method that helps change behavior, is widely used and considered safe. Overall, existing research indicates that both treatments are safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using brain stimulation combined with psychotherapy for treating alcoholism. Unlike standard treatments, which typically involve medication or traditional therapy, this approach uses transcranial alternating current stimulation (tACS) to enhance the effects of motivational interviewing. This method aims to directly influence brain activity related to addiction and motivation, potentially offering a more effective and targeted treatment. By integrating active stimulation with psychotherapy, this innovative approach could lead to faster and more sustained recovery outcomes for individuals struggling with alcohol dependence.

What evidence suggests that this trial's treatments could be effective for alcoholism?

Research has shown that transcranial alternating current stimulation (tACS) could be a promising treatment for alcohol use disorder. This method involves non-invasive brain stimulation, meaning it doesn't require surgery or entering the body. Studies suggest that tACS can help reduce cravings and lower the risk of early relapse for people recovering from alcohol use disorder. One study found that tACS is safe and might also help those dealing with both alcohol and gambling issues.

Motivational interviewing (MI) is another approach proven effective in reducing alcohol use. Research indicates that MI can significantly decrease heavy drinking and keep people engaged in their treatment. In this trial, participants will receive either MI with active tACS, MI with sham stimulation, or MI-only. Overall, both tACS and MI have strong evidence supporting their potential to help with alcohol use disorder. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for right-handed individuals aged 21-60 who recognize they have a drinking problem, as indicated by their AUDIT score. They must not be currently in treatment for alcohol use disorder or have been treated in the past year, and should not have severe alcohol withdrawal history or other substance use disorders (except marijuana or nicotine).

Inclusion Criteria

You are right-handed.

AUDIT score indicating risky drinking

You consider yourself to have a drinking problem.

Exclusion Criteria

I cannot use American Sign Language for psychotherapy due to my hearing impairment.

You cannot have an MRI or transcranial alternating current stimulation (tACS) if you are pregnant.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive motivational interviewing with either active tACS, sham stimulation, or no stimulation

1 session

1 visit (in-person)

Follow-up

Participants report their alcohol use in the prior 30 days via an online assessment battery

4 weeks

1 visit (virtual)

Imaging

Participants undergo MEG and MRI scans to measure the effects of brain stimulation

1 session

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High-density transcranial alternating current stimulation
• Motivational interviewing

Trial Overview The study tests if brain stimulation (tACS) can improve motivational interviewing therapy's effectiveness for people with risky drinking habits. Participants will either receive active stimulation during therapy, sham (fake) stimulation, or be placed in a delayed-treatment group without any brain stimulation.

How Is the Trial Designed?

Group I: MI with tACS Experimental Treatment 2 Interventions

Motivational interviewing with concurrent active stimulation

Group II: MI-only Active Control 1 Intervention

Motivational interviewing only, delayed treatment control

Group III: MI with sham Placebo Group 2 Interventions

Motivational interviewing with concurrent sham stimulation

Who Is Running the Clinical Trial?

The Mind Research Network

Lead Sponsor

Trials

27

Recruited

2,300+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

A survey of 36 motivational interviewing (MI) trainers identified key preferences for the format, duration, and content of beginner-level MI training aimed at addiction treatment, highlighting the need for effective training methods.

The survey also revealed common challenges faced by novice trainers in delivering MI training and provided recommended strategies to overcome these barriers, which is crucial for improving the implementation of evidence-based practices in community treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for New Motivational Interviewing Trainers When Training Addiction Professionals: Findings from a Survey of Experienced Trainers. Schumacher, JA., Coffey, SF., Walitzer, KS., et al.[2021]

Integrating Motivational Interviewing (MI) with Brief Behavioral Activation Therapy for Depression (BATD) aims to enhance patient motivation, which is crucial for adherence to treatment assignments.

This combined approach not only maintains the empirical support for BATD but also addresses the common challenge of low adherence by focusing on motivation, potentially leading to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Motivational Interviewing and Brief Behavioral Activation Therapy: Theoretical and Practical Considerations. Balán, IC., Lejuez, CW., Hoffer, M., et al.[2022]

A brief intervention combining behavioral activation and motivational interviewing significantly reduced alcohol consumption among 9 men in Kenya, with participants drinking 50% less and having 5.1 times higher odds of not drinking post-treatment.

The intervention also led to improvements in depression symptoms and family-related outcomes, indicating its potential effectiveness in addressing both problem drinking and its impact on family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multiple baseline study of a brief alcohol reduction and family engagement intervention for fathers in Kenya. Giusto, A., Green, EP., Simmons, RA., et al.[2021]

In a study involving 398 young people with alcohol-related injuries, the QuikFix intervention, which included personalized coping skills training, led to significantly greater reductions in alcohol consumption at 12 months compared to standard motivational interviewing (MI) and assessment feedback/information (AF/I).

Participants receiving QuikFix reported fewer drinking days and lower average drinks per drinking day, demonstrating that tailored interventions can be more effective in reducing risky alcohol use among young individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-based motivational interviewing enhanced with individualised personality-specific coping skills training for young people with alcohol-related injuries and illnesses accessing emergency or rest/recovery services: a randomized controlled trial (QuikFix). Hides, L., Quinn, C., Chan, G., et al.[2022]

Motivational interviewing (MI) is an effective technique for helping patients recognize the need for change in their habits, such as alcohol dependence, by moving them from complacency to a desire for improvement.

The collaborative nature of MI involves using tools like the decisional balance sheet to help patients weigh the pros and cons of their habits, facilitating a personalized approach to treatment based on their readiness for change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychiatrist's Guide to Motivational Interviewing. Griffith, LJ.[2021]

Motivational interviewing has been validated as an effective nursing intervention to improve treatment adherence in patients with severe mental illnesses, based on a study that included both theoretical and empirical validation phases.

The intervention was standardized for inclusion in the Nursing Interventions Classification (NIC), which may enhance its use by mental health nurses and improve overall quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing: Validation of a proposed NIC nursing intervention in persons with a severe mental illness. Lozano, P., Butcher, HK., Serrano, C., et al.[2021]

Detoxification is often the first step in alcoholism treatment for over 700,000 people in the U.S. daily, and it can be combined with behavioral therapies like cognitive-behavioral therapy and Alcoholics Anonymous.

A major clinical study, Project MATCH, found no significant differences in outcomes among various behavioral treatment approaches, suggesting that the choice of therapy may depend more on individual patient characteristics rather than the type of therapy itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholism treatment in the United States. An overview. Fuller, RK., Hiller-Sturmhöfel, S.[2023]

Motivational Interviewing (MI) has proven effective in helping patients with substance use and psychiatric disorders, particularly when their ambivalence hinders progress in therapy.

The success of MI relies heavily on the caregiver's communication skills, especially in fostering 'change talk' from patients, suggesting that training in MI techniques should be included in psychiatric education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing in psychiatry]. Mechtcheriakov, S., Rettenbacher, M.[2021]

Cognito-behavioral therapy for alcohol dependence emphasizes improving social integration and conditioning, which are crucial for effective treatment.

The therapy can be tailored to individual needs or conducted in groups, adapting to the patient's level of neuropsychological impairment and motivation, enhancing its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Alcoholism: cognitive-behavioral therapy]. Uehlinger, C.[2019]

The Brief Negotiation Interview (BNI) effectively reduces harmful drinking in patients when used in emergency settings, demonstrating its efficacy as a brief intervention tool.

The BNI employs motivational interviewing techniques that can also be applied to address other harmful behaviors, suggesting a broader potential for improving patient care beyond just alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experts: despite time constraints, motivational interviewing techniques can have lasting impact on drinkers, drug abusers. [2019]

The case study demonstrates the effectiveness of the SBIRT approach, which includes screening and motivational interviewing, in addressing alcohol and drug use among culturally diverse populations, specifically in a primary care setting.

This intervention was applied to a Latino patient dealing with hazardous drinking, depression, and chronic pain, highlighting the importance of culturally adapted treatment strategies in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural Adaptation of Screening, Brief Intervention and Referral to Treatment Using Motivational Interviewing. Satre, DD., Manuel, JK., Larios, S., et al.[2021]

The cognitive-behavioral model for treating alcoholism focuses on social learning and conditioning, aiming to change behaviors by teaching new skills and avoidance strategies.

Therapies are tailored to individual or group needs, considering the patient's neuropsychological impairment and motivation, which helps in setting specific treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavior therapy for the treatment of alcoholism]. Uehlinger, C.[2018]

Motivational interviewing and cognitive behaviour therapy were found to produce short-term treatment outcomes for patients with substance use disorders, with motivational interviewing particularly effective in sustaining motivation.

Motivational enhancement therapy showed significant effectiveness in addressing underlying issues and enhancing motivation for treatment, while cognitive behaviour therapy had both short-term impacts and long-term benefits in managing cognitive and behavioral challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Leading Role Of Evidence-Based Practices In The Treatment Of Patients With Substance Use Disorders: A Systematic Review. Shahzadi, M., Hafeez, S., Abbas, Q., et al.[2023]

A clinical trial involving 57 heavy drinking Latinos showed that both culturally adapted and unadapted motivational interviewing significantly reduced heavy drinking days and drinking-related problems over 6 months, with high retention rates of 86% and 84%.

Culturally adapted motivational interviewing was particularly effective, leading to greater reductions in drinking consequences at both 2 months and 6 months, suggesting that cultural adaptation enhances the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally adapted motivational interviewing for Latino heavy drinkers: results from a randomized clinical trial. Lee, CS., López, SR., Colby, SM., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0001691825002525

Effectiveness of transcranial alternating current stimulation ... Employing tDCS to target particular brain areas has demonstrated potential in mitigating cravings (Hone-Blanchet et al., 2015).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7007491/

Non-invasive Brain Stimulation for Alcohol Use Disorders Currently available data generally supports the use of non-invasive brain stimulation as a near-term treatment for alcohol use disorder.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21006331

A randomized placebo-controlled clinical trial Multiple sessions of prefrontal tDCS reduced the rate of early relapse in detoxified patients with alcohol-use disorder.

4. researchgate.net researchgate.net/publication/396772523_High-intensity_transcranial_alternating_current_stimulation_for_gambling_disorder_comorbidities_with_alcohol_use_disorders_A_case_report

High-intensity transcranial alternating current stimulation ... The intervention was well‐tolerated. Discussion and Conclusions HI‐tACS is a safe, efficacious potential treatment for GD‐AUD comorbidity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8815795/

Alpha-tACS effect on inhibitory control and feasibility of ... To our knowledge, this is the first study of tACS in adults with a SUD. Our findings provide preliminary evidence for recruitment, retention, and administration ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41121731/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1r_ozhVnyKqne8dwoosUcmBM1VvTC7u5lopeUKG5GX8FtFFIvC&fc=None&ff=20251022223850&v=2.18.0.post22+67771e2

High-intensity transcranial alternating current stimulation ... Discussion and conclusions: HI-tACS is a safe, efficacious potential treatment for GD-AUD comorbidity. Scientific significance: This first ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6123849/

Adverse events of tDCS and tACS: A review - PubMed Central No serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; for tACS, ...

8. withpower.com withpower.com/trial/phase-3-alcoholism-8-2020-1dbdc

Brain Stimulation + Psychotherapy for Alcoholism ... safety data for brain stimulation techniques like high-density transcranial alternating current stimulation (tACS) combined with psychotherapy for alcoholism.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT05907707/Prot_SAP_000.pdf

Effects of Transcranial Alternating Current Stimulation ( ... • Indication for alcohol use disorder: AUDIT score (Alcohol Use Disorders Identification Test; screening for unhealthy alcohol use) ≥7 for ...