Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.
What safety data exists for tDCS and TUS in treating opioid use disorder?The studies reviewed indicate that transcranial direct current stimulation (tDCS) is generally safe, with no significant side effects reported in various trials involving substance use disorders, including opioid use disorder. For instance, a study on smokers found no significant side effects of tDCS. However, while tDCS has shown potential in reducing cravings and negative affect, its effects on relapse rates and optimal stimulation parameters require further investigation. The safety of combining tDCS with transcranial ultrasound stimulation (TUS) specifically for opioid use disorder is not directly addressed in these studies, suggesting a need for more targeted research.12367
Is tDCS a promising treatment for opioid use disorder?Yes, tDCS is a promising treatment for opioid use disorder. It can help reduce cravings and improve mood, which are important for recovery. Studies show it can change brain activity in ways that might help people with addiction.13678
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you recently started on antiepileptic drug therapy, you cannot participate.
What data supports the idea that tDCS + TUS for Opioid Use Disorder is an effective treatment?The available research shows that tDCS, a type of brain stimulation, can help reduce cravings in people with opioid use disorder. One study found that tDCS reduced cravings in patients on medication for opioid use disorder. Another study showed that tDCS helped reduce cravings in former heroin users. A meta-analysis of multiple studies confirmed that tDCS effectively reduces cravings for opioids and other substances. This suggests that tDCS is a promising treatment for managing cravings in opioid use disorder.34569
Eligibility Criteria
This trial is for adults aged 18-85 with opioid use disorder (OUD) and chronic pain, who have been diagnosed according to DSM-5 criteria. Participants must consent to the study, live locally without relocation plans, and can't be on high doses of methadone. Excluded are pregnant individuals, those with a history of illegal stimulant use or certain neurological disorders, recent brain surgery patients, or those on new antiepileptic drugs.Inclusion Criteria
I am between 18 and 85 years old.
I have severe depression based on standard tests.
I currently have cancer.
Exclusion Criteria
I have had fainting spells that doctors couldn't explain.
I have had brain surgery.
Treatment Details
The study tests if transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) helps treat addiction in people with OUD and chronic pain. It compares active stimulation's effects on drug use reduction and psychosocial improvement against sham (fake) treatments.
2Treatment groups
Active Control
Placebo Group
Group I: Active (tDCS) + Active TUSActive Control1 Intervention
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
Group II: Sham (tDCS) + Sham TUSPlacebo Group1 Intervention
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Find a clinic near you
Research locations nearbySelect from list below to view details:
University Hospitals Cleveland Medical Center/ Dahms Clinical Research UnitCleveland, OH
University of Illinois Health/ University of Illinois at ChicagoHinsdale, IL
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Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
Highland Instruments, Inc.Industry Sponsor
References
Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. [2022]Transcranial Direct Current Stimulation (tDCS) has been shown to reduce acute substance craving in drug addicts, and improve cognition in neuropsychiatric patients. Here we aimed to explore further tDCS induced behavioral and neurophysiological modulation including assessment of relapse rate over a prolonged time course in alcoholism. We examined the effects of repeated anodal tDCS (2mA, 35 cm(2), 20min) over the left dorsolateral prefrontal cortex (DLPFC) on relapse to the use of alcohol in alcoholics from outpatient services, who received additional routine clinical treatment. Furthermore, event related potentials (ERPs), cognitive and frontal executive processes, craving, depressive and anxiety symptoms were obtained before and after treatment. From thirteen alcoholic subjects, seven were randomized to sham-tDCS and six to real tDCS treatment (once a week for five consecutive weeks). Depressive symptoms and craving were reduced to a larger extent in the tDCS group compared to the sham group (p=0.005 and p=0.015, respectively). On the other hand, active tDCS was able to block the increase in neural activation triggered by alcohol related and neutral cues in prefrontal cortex (PFC) as indexed by ERP as seen in the sham-tDCS group. Finally, there was a trend for increased change in executive function in the tDCS group compared to the sham-tDCS group (p=0.082), and, similarly, a trend for more relapses in the tDCS group compared to sham tDCS (four alcoholic subjects (66.7%) vs. one (14.3%), p=0.053).These results confirm the previous findings of tDCS effects on craving in alcoholism and also extend these findings as we showed also tDCS-related mood improvement. However, potential increase in relapse is possible; thus the clinical value of an increase in craving and improvement in depression and executive function needs to be carefully assessed in further studies; including investigation of optimal parameters of stimulation.
Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. [2021]Transcranial direct current stimulation (tDCS) can enhance cognitive control functions including attention and top-down regulation over negative affect and substance craving in both healthy and clinical populations, including early abstinent (∼1.5 h) smokers. The aim of this study was to assess whether tDCS modulates negative affect, cigarette craving, and attention of overnight abstinent tobacco dependent smokers. In this study, 24 smokers received a real and a sham session of tDCS after overnight abstinence from smoking on two different days. We applied anode to the left dorsolateral prefrontal cortex and cathode to the right supra-orbital area for 20 min with a current of 2.0 mA. We used self-report questionnaires Profile of Mood States (POMS) to assess negative affect and Urge to Smoke (UTS) Scale to assess craving for cigarette smoking, and a computerized visual target identification task to assess attention immediately before and after each tDCS. Smokers reported significantly greater reductions in POMS scores of total mood disturbance and scores of tension-anxiety, depression-dejection, and confusion-bewilderment subscales after real relative to sham tDCS. Furthermore, this reduction in negative affect positively correlated with the level of nicotine dependence as assessed by Fagerström scale. However, reductions in cigarette craving after real vs. sham tDCS did not differ, nor were there differences in reaction time or hit rate change on the visual task. Smokers did not report significant side effects of tDCS. This study demonstrates the safety of tDCS and its promising effect in ameliorating negative affect in overnight abstinent smokers. Its efficacy in treating tobacco dependence deserves further investigation.
Transcranial direct current stimulation of the frontal-parietal-temporal area attenuates cue-induced craving for heroin. [2022]Transcranial direct current stimulation (tDCS) is an effective approach to modulate brain region functions. We assessed if a single tDCS session over the bilateral frontal-parietal-temporal (FPT) areas would reduce cue induced craving in heroin addicts.
Modulation of Drug Craving in Crystalline-Heroin Users by Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex. [2022]Drug craving, the main cause of relapse and a major motivator for drug use, is a challenging obstacle in substance use treatment. Transcranial direct current stimulation (tDCS), a non-invasive neuromodulatory technique, has shown promising outcomes in treating different neuropsychiatric disorders such as drug addiction, more specifically on drug craving. The aim in the current study was to examine the effects of applying tDCS on dorsolateral prefrontal cortex (DLPFC) in reducing drug cravings in former crystalline-heroin users enrolled in methadone maintenance (MMT) programs.
Transcranial direct current stimulation (tDCS) may reduce the expired CO concentration among opioid users who smoke cigarettes: a randomized sham-controlled study. [2022]Transcranial direct current stimulation (tDCS) could be a potential treatment for nicotine dependency. Little is known with regards to the efficacy of this treatment in cigarette-smoking patients with heroin dependency. In this sham-controlled study, we probed the effect of 5-day, 20-min, 2-mA-intensity tDCS treatment on the outcomes of cigarette-smoking. Our objectives are to examine the effects of tDCS on two outcomes: objective expired CO concentration and subjective self-reported number of cigarettes smoked per day. A total of 30 patients were randomized into active or sham control groups. The stimulation site was randomized to anodal stimulation of the left dorsal lateral prefrontal cortex or the orbital frontal cortex. The expired CO concentration was recorded. The patients also reported their cigarette consumption and level of craving prior to each 5-day treatment period and after 5 days of follow-up. tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked. However, no significant group difference was found with regards to craving tendency. tDCS may affect objective outcomes related to cigarette-smoking among patients with heroin dependence.
Adjunctive High-Definition Transcranial Direct Current Stimulation in Brain Glutamate-Glutamine and γ-Aminobutyric Acid, Withdrawal and Craving During Early Abstinence Among Patients With Opioid Use Disorder on Buprenorphine-Naloxone: A Proton Magnetic Resonance Spectroscopy-Based Pilot Study. [2023]Our study aimed to (1) examine the effect of adjunctive high-definition transcranial direct current stimulation (HD-tDCS) in craving and withdrawal among patients with opioid use disorder on buprenorphine-naloxone, and (2) examine effect of HD-tDCS changes in glutamate-glutamine and γ-aminobutyric acid (GABA) at the left dorsolateral prefrontal cortex (DLPFC) among patients with opioid use disorder on buprenorphine-naloxone.
Transcranial direct current stimulation to modulate fMRI drug cue reactivity in methamphetamine users: A randomized clinical trial. [2023]Transcranial direct current stimulation (tDCS) has been studied as a therapeutic option to alter maladaptive brain functions associated with chronic substance use. We present a randomized, triple-blind, sham-controlled, clinical trial to determine the neural substrates of tDCS effects on drug craving. Sixty participants with methamphetamine use disorder were assigned to two groups: active tDCS (5 x 7 cm2 , 2 mA, 20 min, anode/cathode over the F4/Fp1) and sham stimulation. Neuroimaging data of a methamphetamine cue reactivity task were collected immediately before and after stimulation. There was a significant reduction in self-reported craving after stimulation without any significant effect of time-by-group interaction. Our whole-brain analysis demonstrated that there was a global decrease in brain reactivity to cues following sham but not active tDCS. There were significant time-by-group interactions in five main clusters in middle and inferior frontal gyri, anterior insula, inferior parietal lobule, and precuneus with higher activations after active stimulation. There was a significant effect of stimulation type in the relationship between electrical current at the individual level and changes in task-modulated activation. Brain regions with the highest electric current in the prefrontal cortex showed a significant time-by-group interaction in task-modulated connectivity in the frontoparietal network. In this trial, there was no significant effect of the one session of active-F4/Fp1 tDCS on drug craving self-report compared to sham stimulation. However, activation and connectivity differences induced by active compared to sham stimulation suggested some potential mechanisms of tDCS to modulate neural response to drug cues.
[Transcranial direct current stimulation in substance use disorders: an update]. [2023]Existing treatments for substance use disorders are often subject to drop-out or relapse. Transcranial direct current stimulation (tDCS) possibly has a positive effect on this problem.
Targeting cravings in substance addiction with transcranial direct current stimulation: insights from a meta-analysis of sham-controlled trials. [2023]Addiction is a substantial health concern; craving-the core symptom of addiction-is strongly associated with relapse. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that reduces cravings by altering cortical excitability and connectivity in brain regions. This systematic review and meta-analysis was conducted (following the PRISMA guidelines) to evaluate the efficacy of tDCS in reducing cravings for substances. Our analysis included 43 randomized, sham-controlled trials involving 1,095 and 913 participants receiving tDCS and sham stimulation, respectively. We analyzed the changes in craving scores and found that tDCS led to a moderate reduction in cravings compared with the sham effects. This effect was particularly pronounced when bilateral stimulation was used, the anodal electrode was placed on the right dorsolateral prefrontal cortex, current intensities ranged from 1.5 to 2 mA, stimulation sessions lasted 20 minutes, and the electrodes size was ≥35 cm². Notably, tDCS effectively reduced cravings for opioids, methamphetamine, cocaine, and tobacco but not for alcohol or cannabis. Our findings indicate tDCS as a promising, noninvasive, and low-risk intervention for reducing cravings for opioids, methamphetamine, cocaine, and tobacco. Additional studies are warranted to refine stimulation parameters and evaluate the long-term efficacy of tDCS in managing substance cravings.