Neuromodulation + Cognitive Training for Substance Use Disorders

Overseen By Melanie Stimac

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurological conditions, TBI, others

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The relapsing nature of substance use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. This study is testing a new intervention, namely tDCS-Augmented Cognitive Training, to engage these brain biomarkers to improve cognition and improve treatment outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be abstinent from any substance or alcohol use (except caffeine or nicotine) for at least 3 weeks before joining the study.

What data supports the effectiveness of the treatment tDCS-Augmented Cognitive Training for Substance Use Disorders?

Research suggests that combining transcranial direct current stimulation (tDCS) with cognitive training can help reduce cravings in individuals with substance use disorders, such as methamphetamine and heroin addiction. Additionally, studies have shown that tDCS can enhance the effects of cognitive interventions, potentially leading to better outcomes in reducing cravings and substance use. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with studies showing it is well tolerated and reporting no significant adverse events in participants with substance use disorders. ^{2 6 7 8 9}

How is the tDCS-Augmented Cognitive Training treatment different from other treatments for substance use disorders?

The tDCS-Augmented Cognitive Training treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with cognitive training to potentially reduce cravings and improve cognitive functions. This approach directly targets brain circuits involved in addiction, offering a novel method compared to traditional pharmacological or behavioral therapies. ^{1 2 3 10 11}

Research Team

Kelvin Lim, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals aged 18-65 with substance use disorders (SUD) or alcohol use disorder (AUD), who have been abstinent for at least 3 weeks but not more than 9 months. Participants must intend to stay in their treatment program and meet specific diagnostic criteria, excluding those with neurological conditions, severe head injuries, recent neuromodulation treatments, or under court-mandated rehab.

Inclusion Criteria

You meet the criteria for having a problem with using stimulant drugs or alcohol.

Able to provide written consent and comply with study procedures

I plan to stay in my treatment program until the study ends.

Exclusion Criteria

I am younger than 18 or older than 65.

I have had a head injury that made me unconscious for more than 30 minutes.

I haven't had ECT or been in neuromodulation studies in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of either active or sham transcranial direct current stimulation (tDCS) while performing executive functioning tasks

3 weeks

10 sessions (in-person)

Follow-up

Follow-up interviews conducted monthly to query relapse status and assess cognitive performance

4 months

Monthly visits (in-person or virtual)

Treatment Details

Interventions

• tDCS
• tDCS-Augmented Cognitive Training

Trial Overview The study tests tDCS-Augmented Cognitive Training aimed at improving cognition and treatment outcomes for SUD/AUD. It targets brain biomarkers associated with relapse vulnerability by combining transcranial direct current stimulation (tDCS) with cognitive exercises.

Participant Groups

Group I: Active tDCS Experimental Treatment 2 Interventions

Group II: Sham tDCS Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

In a study involving 75 female patients with methamphetamine use disorder, combining transcranial direct current stimulation (tDCS) with computerized cognitive addiction therapy (CCAT) significantly reduced cue-induced craving after 4 weeks compared to control groups.

The CCAT + tDCS group also showed improved cognitive function, specifically in task accuracy, indicating that this combined intervention may enhance treatment outcomes for individuals with methamphetamine use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The transcranial direct current stimulation over prefrontal cortex combined with the cognitive training reduced the cue-induced craving in female individuals with methamphetamine use disorder: A randomized controlled trial. Xu, X., Ding, X., Chen, L., et al.[2021]

Transcranial direct current stimulation (tDCS) has been shown to positively impact clinical measures such as craving and abstinence in individuals with substance use disorders, based on a review of 43 studies.

Despite the promising results, there is a lack of uniformity in the treatment protocols used, indicating that optimal parameters for tDCS need to be established to enhance its effectiveness for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in substance use disorders: an update]. Tobback, H., Deroost, N., Baeken, C., et al.[2023]

Transcranial direct current stimulation (tDCS) combined with cognitive bias modification (CBM) did not show a significant enhancement in treatment outcomes for alcohol-dependent patients, as there was no effect on abstinence duration after three months.

However, there was a trend suggesting that tDCS during CBM may reduce relapse rates after one year compared to sham stimulation, indicating potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. den Uyl, TE., Gladwin, TE., Rinck, M., et al.[2018]

A single session of transcranial direct current stimulation (tDCS) applied to the bilateral frontal-parietal-temporal areas significantly reduced craving scores in 20 long-term heroin addicts, demonstrating its potential efficacy in managing addiction-related cravings.

No side effects were reported from the tDCS treatment, indicating that it is a safe intervention for reducing cue-induced cravings in heroin addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the frontal-parietal-temporal area attenuates cue-induced craving for heroin. Wang, Y., Shen, Y., Cao, X., et al.[2022]

A combined intervention of psychoeducation (PE) and transcranial direct current stimulation (tDCS) significantly enhances the ability to reduce cigarette consumption compared to PE alone, as shown in two experiments involving 67 male smokers.

Repeated sessions of PE not only reduce cravings and cigarette intake during the intervention but also help maintain lower smoking levels for at least a week after the intervention ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of psychoeducation combined with transcranial direct current stimulation on reducing cigarette craving and consumption in male smokers. Qin, J., Chen, J., Wang, Y., et al.[2023]

In a clinical trial involving 60 participants with methamphetamine use disorder, active transcranial direct current stimulation (tDCS) did not significantly reduce self-reported drug craving compared to sham stimulation, indicating limited immediate efficacy in craving reduction.

However, neuroimaging results showed that active tDCS led to increased brain activation and connectivity in key areas associated with craving response, suggesting potential mechanisms by which tDCS may modulate neural responses to drug cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to modulate fMRI drug cue reactivity in methamphetamine users: A randomized clinical trial. Ekhtiari, H., Soleimani, G., Kuplicki, R., et al.[2023]

Anodal transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) significantly reduced attentional bias towards drug cues in early-abstinent methamphetamine users, suggesting a potential therapeutic effect.

The study involved 90 participants and compared different electrode montages, with specific configurations showing effectiveness in modifying attentional bias, highlighting the need for further research on optimal tDCS protocols for addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Electrode Montages of Transcranial Direct Current Stimulation for Attentional Bias Modification in Early Abstinent Methamphetamine Users. Shahbabaie, A., Hatami, J., Farhoudian, A., et al.[2020]

In a clinical trial involving 35 crack-cocaine patients, 10 sessions of real transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (dlPFC) showed a significant reduction in craving scores compared to sham treatment, with an effect size of 0.34 favoring the real tDCS group.

Despite the reduction in craving, the study found no significant difference in relapse rates between the real tDCS and sham groups after 30 and 60 days, suggesting that while tDCS may help with craving, it does not significantly impact relapse rates in crack-cocaine use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of Effects of Extended Sessions of Transcranial Direct Current Stimulation (tDCS) Over Dorsolateral Prefrontal Cortex on Craving and Relapses in Crack-Cocaine Users. Klauss, J., Anders, QS., Felippe, LV., et al.[2020]

In a clinical trial involving alcohol use disorder patients, 10 sessions of transcranial direct current stimulation (tDCS) significantly reduced alcohol craving scores compared to a sham treatment, with a large effect size of 1.1 for the real tDCS group.

The study found that 72.7% of patients receiving real tDCS remained abstinent from alcohol after 3 months, while 72.2% of the sham group relapsed, suggesting that tDCS may be an effective adjunctive treatment for reducing relapse in alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. Klauss, J., Anders, QS., Felippe, LV., et al.[2020]

Neuromodulation methods like repetitive transcranial magnetic stimulation (rTMS) have shown medium to large effects in reducing substance use and cravings in individuals with substance use disorders, especially when targeting the left dorsolateral prefrontal cortex (DLPFC) with multiple sessions.

Transcranial direct current stimulation (tDCS) also demonstrated medium effects on drug use and cravings, but results were more variable compared to rTMS, with right anodal DLPFC stimulation being the most effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of neuromodulation therapies for substance use disorders. Mehta, DD., Praecht, A., Ward, HB., et al.[2023]

Neuromodulation techniques, such as rTMS and tDCS, have shown promise in reducing immediate cravings for addictive substances, but their long-term effectiveness and the high placebo response rates need further investigation.

Deep brain stimulation (DBS) has reported cases of prolonged abstinence from opioids and alcohol, suggesting its potential in addiction treatment, but challenges in patient inclusion highlight the need for more controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Invasive and Non-Invasive Brain Modulation Interventions for Addiction. Luigjes, J., Segrave, R., de Joode, N., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

The transcranial direct current stimulation over prefrontal cortex combined with the cognitive training reduced the cue-induced craving in female individuals with methamphetamine use disorder: A randomized controlled trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in substance use disorders: an update]. [2023]

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

A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the frontal-parietal-temporal area attenuates cue-induced craving for heroin. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of psychoeducation combined with transcranial direct current stimulation on reducing cigarette craving and consumption in male smokers. [2023]

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

Transcranial direct current stimulation to modulate fMRI drug cue reactivity in methamphetamine users: A randomized clinical trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing Electrode Montages of Transcranial Direct Current Stimulation for Attentional Bias Modification in Early Abstinent Methamphetamine Users. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Lack of Effects of Extended Sessions of Transcranial Direct Current Stimulation (tDCS) Over Dorsolateral Prefrontal Cortex on Craving and Relapses in Crack-Cocaine Users. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of neuromodulation therapies for substance use disorders. [2023]

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

Efficacy of Invasive and Non-Invasive Brain Modulation Interventions for Addiction. [2020]