Neurostimulation for Addiction

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Psychotropics, Cancer meds, Epilepsy meds

Disqualifiers: Seizure disorder, Cognitive impairments, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to help adults reduce their desire for drugs by using a gentle technique that affects the brain. The goal is to support existing treatments with fewer side effects and better commitment to the treatment plan.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications for ADHD, mental illness, cancer, epilepsy, migraines, or other neurological conditions.

What data supports the effectiveness of this treatment for addiction?

Research shows that transcranial direct current stimulation (tDCS), a part of the treatment, can help reduce cravings in people with substance use disorders, including methamphetamine and heroin addiction. A meta-analysis also found that non-invasive brain stimulation techniques like tDCS have a medium effect size in reducing cravings compared to placebo treatments. ^{1 2 3 4 5}

Is neurostimulation safe for humans?

Research on Temporal Interference Transcranial Alternating Current Stimulation (TI-tACS), a type of non-invasive brain stimulation, shows it is generally safe and tolerable in humans, with no serious or intolerable side effects reported in studies. This suggests that similar neurostimulation techniques, like Transcranial Direct Current Stimulation (tDCS), are also likely to be safe for human use. ^{1 2 3 4 6}

How is the treatment for addiction using neurostimulation different from other treatments?

This treatment uses non-invasive brain stimulation techniques like Transcranial Direct Current Stimulation (tDCS) and Temporal Interference Neurostimulation (TI-NDBS) to help control drug cravings, which is different from traditional methods that often rely on medication or therapy. It targets specific brain areas to reduce cravings, offering a novel approach for those who may not respond well to standard treatments. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

Adults aged 18-40 who smoke at least three-quarters of a pack of cigarettes daily, can speak and read English, have at least a 6th-grade education, and own a phone with internet. Excluded are those with cranial abnormalities or metal implants, IUD users without safety documentation for MRI, pregnant individuals, those over 440 lbs., pacemaker users, people on certain medications including psychotropics or with cognitive impairments.

Inclusion Criteria

You need to smoke at least 15 cigarettes per day.

I am between 18 and 40 years old.

Must have phone with internet access

Exclusion Criteria

I am on medication for ADHD, mental illness, cancer, epilepsy, migraines, neurological syndromes, or AIDS.

You have had holes or openings made in your skull in the past, or you have known cracks or breaks in the bones of your head.

I weigh less than 440 lbs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Feasibility

Identify the best locations for electrode placement for TI-NDBS

4 weeks

Phase 3 Treatment

Participants receive active or sham TI-NDBS for 60 minutes on one day

1 day

Phase 4 Treatment

Participants receive active TI-NDBS, sham stimulation, or traditional tDCS for 60 minutes over 5 days

5 days

Follow-up

Participants are monitored for changes in nicotine craving and smoking behavior

1 year

Treatment Details

Interventions

• Active TI-NDBS (Neurostimulation)
• Sham TI-NDBS (Behavioural Intervention)
• tDCS (Neurostimulation)

Trial Overview The study is testing new non-invasive neurostimulation technologies—Active TI-NDBS and tDCS—against a sham (placebo) intervention to treat opioid use disorders by targeting specific brain regions. The goal is to disrupt addiction behaviorally and neurally as groundwork for future clinical trials.

Participant Groups

Group I: Phase 4 TI-NDBS Experimental Treatment 1 Intervention

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.

Group II: Phase 3 Active TI-NDBS Experimental Treatment 1 Intervention

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.

Group III: Phase 4 Traditional tDCS Active Control 1 Intervention

Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.

Group IV: Phase 4 Sham stimulation Placebo Group 1 Intervention

Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds. Participants will be in the scanner for 60 minutes for 5 days. This will be used as the control condition and compared with TI-NDBS and tDCS.

Group V: Phase 3 Sham TI-NDBS Placebo Group 1 Intervention

Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Jay L. Hess

Indiana University School of Medicine

Chief Executive Officer since 2013

PhD in Medical and Molecular Genetics from Indiana University School of Medicine

Mara Nitu

Indiana University School of Medicine

Chief Medical Officer

MD from Carol Davila University of Medicine and Pharmacy

Findings from Research

Transcranial direct current stimulation (tDCS) shows promise in reducing food cravings in individuals with behavioral addictions, particularly in studies focusing on eating disorders.

Only seven studies were reviewed, indicating a need for more research on the efficacy of tDCS for various behavioral addictions beyond just eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) in behavioral and food addiction: a systematic review of efficacy, technical, and methodological issues. Sauvaget, A., Trojak, B., Bulteau, S., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has shown cumulative effects in reducing methamphetamine cravings and associated cognitive impairments in a methamphetamine-dependent subject, indicating its potential as a therapeutic intervention.

Booster sessions of tDCS may further help in managing psychological stress and cravings, suggesting that ongoing treatment could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative and booster effects of tdcs sessions on drug cravings, lapse, and cognitive impairment in methamphetamine use disorder: A case study report. Shariatirad, S., Vaziri, A., Hassani-Abharian, P., et al.[2022]

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]

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]

Non-invasive neurostimulation techniques, specifically repetitive Transcranial Magnetic Stimulation (rTMS) and transcranial Direct Current Stimulation (tDCS), significantly reduce craving levels in individuals with substance dependence and for high palatable food, with a medium effect size of 0.476 based on 17 studies.

The analysis found no significant differences in effectiveness between rTMS and tDCS, or among different substances of abuse, indicating that both techniques are similarly effective in targeting cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of non-invasive neurostimulation on craving: a meta-analysis. Jansen, JM., Daams, JG., Koeter, MW., et al.[2022]

In a study involving 38 healthy adults, temporal interference transcranial alternating current stimulation (TI-tACS) was found to be safe, with no significant adverse effects reported after active stimulation at 2 mA for 30 minutes.

The study showed no significant differences in neurological and neuropsychological measurements between the active TI-tACS group and the sham group, indicating that TI-tACS does not negatively impact brain function under the tested conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Employing Temporal Interference Transcranial Alternating Current Stimulation in Human Studies. Piao, Y., Ma, R., Weng, Y., et al.[2022]

References

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

Transcranial direct current stimulation (tDCS) in behavioral and food addiction: a systematic review of efficacy, technical, and methodological issues. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cumulative and booster effects of tdcs sessions on drug cravings, lapse, and cognitive impairment in methamphetamine use disorder: A case study report. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Effects of non-invasive neurostimulation on craving: a meta-analysis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Employing Temporal Interference Transcranial Alternating Current Stimulation in Human Studies. [2022]