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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help individuals with substance use disorders, such as alcohol or stimulant issues, avoid relapse. It employs tDCS-Augmented Cognitive Training (Transcranial Direct Current Stimulation-Augmented Cognitive Training), which combines brain stimulation with mental exercises to target brain areas associated with relapse. The aim is to enhance thinking skills and treatment success. Participants must be committed to their treatment program, have been substance-free for at least three weeks, and meet specific criteria for alcohol or stimulant use disorders. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future treatment options.

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 prior data suggests that this intervention is safe for substance use disorders?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe. Studies have found no serious side effects, such as brain injury. Some individuals might experience minor issues, like scalp irritation, but these are usually mild and resolve quickly. No effects on heart function or increased risk of seizures have been reported with tDCS. Overall, it is considered a well-tolerated method for non-invasive brain stimulation in adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for substance use disorders focus on medication or behavioral therapy. But the new approach of tDCS-Augmented Cognitive Training stands out by using transcranial direct current stimulation (tDCS) to enhance brain function. This technique delivers a low electrical current to specific areas of the brain, potentially boosting the effectiveness of cognitive training exercises. Researchers are excited because this non-invasive method could lead to more rapid or sustained recovery by directly targeting neural pathways involved in addiction, offering a novel adjunct to existing therapies.

What evidence suggests that tDCS-Augmented Cognitive Training could be an effective treatment for substance use disorders?

Studies have shown that transcranial direct current stimulation (tDCS), which participants in this trial may receive, can help reduce cravings in individuals with substance use disorders, including those involving opioids, methamphetamine, cocaine, and tobacco. tDCS might also enhance thinking skills, often impaired in people with these disorders, and ease withdrawal symptoms. Research indicates that the application method and duration of tDCS can influence its effectiveness. Overall, these findings suggest that tDCS could be a valuable tool in managing substance use disorders. ^{3 6 7 8 9}

Who Is on the Research Team?

Kelvin Lim, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

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Targeting cravings in substance addiction with transcranial ... Our findings indicate tDCS as a promising, noninvasive, and low-risk intervention for reducing cravings for opioids, methamphetamine, cocaine, and tobacco.

2. mdpi.com mdpi.com/2076-3425/14/8/754

Is Transcranial Direct Current Stimulation Effective for ... Twenty-two studies met the criteria, suggesting tDCS can improve cognitive functions in SUD patients, though results varied. Effectiveness may depend on the ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00598/full

A Meta-Analysis of Transcranial Direct Current Stimulation ... In conclusion, our results provided evidence that tDCS can be an effective way to reduce craving of substance or food, and longer multiple stimulus durations in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262281/

Impact of Transcranial Direct Current Stimulation on Ultra- ... The study's results support the hypothesis that tDCS reduces craving and withdrawal symptoms caused by treating opioid addiction with ultra-rapid opioid ...

5. nature.com nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ... Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X16301401

Safety of Transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05350033

Transcranial Direct Current Stimulation on Inhibitory ... In addition, no adverse effects on cardiac function have been found from stimulation and no convulsive effects have been associated with tDCS. However, to ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178118315312

Tolerance of transcranial direct current stimulation in ... In summary, our observations suggest that tDCS is a safe mode for therapeutic non-invasive neuromodulation in psychiatric disorders in adults as well as the ...