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.
12345Is 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.
26789How 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.
1231011Eligibility 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.
+1 more
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.
+5 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment2 Interventions
Group II: Sham tDCSPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Minnesota FairviewMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
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]Craving and cognitive deficits are potential treatment targets for methamphetamine use disorder (MUD). Previous studies implied that transcranial direct current stimulation (tDCS) and cognitive training respectively improve these symptoms, but the combined effect is unknown. In this study, we investigated the combined effects of tDCS over dorsolateral prefrontal cortex (DLPFC) and computerized cognitive addiction therapy (CCAT) on cue-induced craving and cognitive functions among female individuals with MUD.
[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.
A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. [2018]Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase neuroplasticity and has previously been found to reduce craving. One hundred alcohol-dependent inpatients (91 used for analysis) were randomized into three experimental groups in a double-blind parallel design. The experimental group received four sessions of CBM while receiving 2 mA of anodal tDCS over the dorsolateral prefrontal cortex (DLPFC). There were two control groups: One received sham stimulation during training and one received active stimulation at a different moment. Treatment outcomes were abstinence duration (primary) and relapse after 3 and 12 months, craving and approach bias (secondary). Craving and approach bias scores decreased over time; there were no significant interactions with experimental condition. There was no effect on abstinence duration after three months (χ2(2) = 3.53, p = 0.77). However, a logistic regression on relapse rates after one year (standard outcome in the clinic, but not-preregistered) showed a trend when relevant predictors were included; relapse was lower in the condition receiving active stimulation during CBM only when comparing to sham stimulation (B = 1.52, S.E. = .836, p = .07, without predictors: p = .19). No strong evidence for a specific enhancement effect of tDCS on CBM was found. However, in a post-hoc analysis, tDCS combined with CBM showed a promising trend on treatment outcome. Important limitations are discussed, and replication is necessary to find more reliable effects.
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.
Effects of psychoeducation combined with transcranial direct current stimulation on reducing cigarette craving and consumption in male smokers. [2023]Psychoeducation (PE) has been widely used in smoking interventions, but its long-term effects are limited. Recent studies have reported that, in some fields, a combination of transcranial direct current stimulation (tDCS) and cognitive training (e.g., working memory tasks) may improve cognitive outcomes; thus, we aimed to investigate whether such a combined intervention has a better effect than a PE intervention for reducing smoking cravings and cigarette consumption. In Exp. 1, 19 male smokers received four types of interventions at one-week intervals. In each session, participants were presented with audio PE (or control) while receiving 2-mA active (or sham) tDCS of the dorsolateral prefrontal cortex (DLPFC). In Exp. 2, 48 male smokers were randomized into four experimental groups (PE + Active, Control + Active, PE + Sham, or Control + Sham). Each participant received one type of five-day intervention (i.e., watching a five-minute PE/Control video twice while receiving 2-mA active/sham tDCS) and was followed up for one week. The results showed (a) an enhancement effect of tDCS on PE's ability to reduce cigarette consumption; (b) that repeated PE has a cumulative effect on reducing both craving and cigarette consumption during the intervention period; and (c) that, compared with PE alone, PE combined with tDCS is capable of helping participants maintain a low intake of cigarettes over one week. These findings suggest that repeated interventions of PE combined with tDCS may be effective in reducing smoking consumption and that further studies are warranted to confirm its application.
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.
Optimizing Electrode Montages of Transcranial Direct Current Stimulation for Attentional Bias Modification in Early Abstinent Methamphetamine Users. [2020]Introduction: Chronic use of most psychoactive drugs may lead to substance dependence and drug addiction. Drug addiction is a chronically relapsing disorder, and current pharmacological and behavioral therapies are not fully efficient. Attentional bias (AB) is hypothesized to have a causal contribution to substance abuse, addiction development and, maintenance. Transcranial direct current stimulation (tDCS) has been of increasing interest in the past few years as a means for modulating neuroplasticity of the human brain. Although several studies have reported promising therapeutic effects for tDCS in drug abusers, there is no consensus about optimal electrode montages and target brain regions. This study was aimed to compare effectiveness of several electrode montages in modifying AB. Methods and Materials: Ninety early-abstinent methamphetamine users were recruited from several residential drug-rehabilitation centers in Tehran province. They were randomly assigned to six groups with different electrode montages, targeting the left or right dorsolateral prefrontal cortex (DLPFC) as follows: Two conditions with anodal tDCS over the right DLPFC (return electrode placed over the left shoulder or left supraorbital ridge), three conditions with the anode positioned over the left DLPFC (return electrode over the right shoulder, right supraorbital ridge, or contralateral DLPFC), and one sham condition. Active stimulation intensity was 2 mA DC, delivered for 13 min followed by a 20-min rest and another 13 min of stimulation. The probe detection task (PDT) was performed to assess AB. The positive and negative affect scale (PANAS), and the depression anxiety stress scales (DASS) were used to assess baseline affective status before the intervention. Results: Mixed model analysis showed that the left DLPFC/right shoulder and left DLPFC/right DLPFC montages reduced AB toward drug-cues in comparison with sham stimulation. Conclusion: Our findings indicate that anodal stimulation over the left DLPFC reduces AB in methamphetamine users. This study offers promising findings for further studies investigating tDCS as a clinical device to modify AB in drug users.
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]Background: Non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) has been investigated as additional therapeutic tool for drug use disorder. In a previous study, we showed that five sessions of tDCS applied bilaterally over the dorsolateral prefrontal cortex (dlPFC) reduced craving to the use of crack-cocaine in inpatients from a specialized clinic. In the present study, we examine if an extended number of sessions of the same intervention would reduce craving even further and affect also relapses to crack-cocaine use. Methods: A randomized, double-blind, sham-controlled, clinical trial with parallel arms was conducted (https://clinicaltrials.gov/ct2/show/NCT02091167). Crack-cocaine patients from two private and one public clinics for treatment of drug use disorder were randomly allocated to two groups: real tDCS (5 cm × 7 cm, 2 mA, for 20 min, cathodal over the left dlPFC and anodal over the right dlPFC, n = 19) and sham-tDCS (n = 16). Real or sham-tDCS was applied once a day, every other day, in a total of 10 sessions. Craving was monitored by a 5-item obsessive compulsive drinking scale once a week (one time before, three times during and once after brain stimulation) over about 5 weeks and relapse was monitored after their discharge from clinics for up to 60 days. Results: Craving scores progressively decreased over five measurements in both sham- and real tDCS groups. Corrected Hedges' within-group (initial and final) effect sizes of craving scores were of 0.77 for the sham-tDCS and of 0.97 for the real tDCS group. The between-groups effect size was of 0.34, in favor of the real tDCS group over sham-tDCS group. Relapse rates were high and quite similar between groups in the 30- and 60-days follow-up after discharge from the hospital. Conclusion: Extended repetitive bilateral tDCS over the dlPFC had no add-on effects over regular treatment when considering craving and relapses to the crack-cocaine use in a sample of crack-cocaine patients with severe use disorder. Different tDCS montages targeting other cortical regions and perhaps additional extension of sessions need to be investigated to reach more efficiency in managing craving and relapses to crack-cocaine use.
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]Background: Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has been studied as an adjunctive therapeutic agent for alcohol dependence. In a previous study, we showed that five consecutive sessions of tDCS applied bilaterally over the dorsolateral prefrontal cortex (dlPFC) reduced relapse to the use of alcohol in alcohol use disorder (AUD) outpatients. However, no changes on craving scores were observed. In the present study, we investigated if an extended number of sessions of the same intervention would reduce craving and relapses for alcohol use in AUD inpatients. Methods: Thus, a randomized, double-blind, sham-controlled, clinical trial with parallel arms was conducted (https://clinicaltrials.gov/ct2/show/NCT02091284). AUD patients from two private and one public clinics for treatment of drug dependence were randomly allocated to two groups: real tDCS (5 × 7 cm2, 2 mA, for 20 min, cathodal over the left dlPFC, and anodal over the right dlPFC) and sham-tDCS. Real or sham-tDCS was applied once a day, every other day, in a total of 10 sessions. Craving was monitored by a 5-item obsessive compulsive drinking scale once a week (one time before, three times during and once after brain stimulation) over about 5 weeks. Results: Craving scores progressively decreased over five measurements in both groups but were significantly reduced only in the real tDCS group after treatment. Corrected Hedges' within-group (initial and final) effect sizes of craving scores were of 0.3 for the sham-tDCS and of 1.1 for the real tDCS group. Effect size was 3-fold larger in the real tDCS group. In addition, the between-group analysis on craving score difference was nearly significant, and the effect size was 0.58, in favor for a larger effect in the real tDCS group when compared to sham-tDCS. Furthermore, in a 3-months follow-up after intervention, 72.2% of sham-tDCS group relapsed to the alcohol use whereas 72.7% of tDCS group were abstinent. Conclusions: Multiple sessions of bilateral prefrontal tDCS were well tolerated with no significant adverse events. Thus, extended repetitive bilateral tDCS over the dlPFC is a promising adjunctive clinical tool that could be used to reduce alcohol craving and relapses and facilitate alcoholism cessation.
A systematic review and meta-analysis of neuromodulation therapies for substance use disorders. [2023]While pharmacological, behavioral and psychosocial treatments are available for substance use disorders (SUDs), they are not always effective or well-tolerated. Neuromodulation (NM) methods, including repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS) and deep brain stimulation (DBS) may address SUDs by targeting addiction neurocircuitry. We evaluated the efficacy of NM to improve behavioral outcomes in SUDs. A systematic literature search was performed on MEDLINE, PsychINFO, and PubMed databases and a list of search terms for four key concepts (SUD, rTMS, tDCS, DBS) was applied. Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (e.g., craving, consumption, and relapse) amongst individuals with SUDs including alcohol, tobacco, cannabis, stimulants, and opioids. Meta-analyses were performed for alcohol and tobacco studies using rTMS and tDCS. We found that rTMS reduced substance use and craving, as indicated by medium to large effect sizes (Hedge's g > 0.5). Results were most encouraging when multiple stimulation sessions were applied, and the left dorsolateral prefrontal cortex (DLPFC) was targeted. tDCS also produced medium effect sizes for drug use and craving, though they were highly variable and less robust than rTMS; right anodal DLPFC stimulation appeared to be most efficacious. DBS studies were typically small, uncontrolled studies, but showed promise in reducing misuse of multiple substances. NM may be promising for the treatment of SUDs. Future studies should determine underlying neural mechanisms of NM, and further evaluate extended treatment durations, accelerated administration protocols and long-term outcomes with biochemical verification of substance use.
Efficacy of Invasive and Non-Invasive Brain Modulation Interventions for Addiction. [2020]It is important to find new treatments for addiction due to high relapse rates despite current interventions and due to expansion of the field with non-substance related addictive behaviors. Neuromodulation may provide a new type of treatment for addiction since it can directly target abnormalities in neurocircuits. We review literature on five neuromodulation techniques investigated for efficacy in substance related and behavioral addictions: transcranial direct current stimulation (tDCS), (repetitive) transcranial magnetic stimulation (rTMS), EEG, fMRI neurofeedback and deep brain stimulation (DBS) and additionally report on effects of these interventions on addiction-related cognitive processes. While rTMS and tDCS, mostly applied at the dorsolateral prefrontal cortex, show reductions in immediate craving for various addictive substances, placebo-responses are high and long-term outcomes are understudied. The lack in well-designed EEG-neurofeedback studies despite decades of investigation impedes conclusions about its efficacy. Studies investigating fMRI neurofeedback are new and show initial promising effects on craving, but future trials are needed to investigate long-term and behavioral effects. Case studies report prolonged abstinence of opioids or alcohol with ventral striatal DBS but difficulties with patient inclusion may hinder larger, controlled trials. DBS in neuropsychiatric patients modulates brain circuits involved in reward processing, extinction and negative-reinforcement that are also relevant for addiction. To establish the potential of neuromodulation for addiction, more randomized controlled trials are needed that also investigate treatment duration required for long-term abstinence and potential synergy with other addiction interventions. Finally, future advancement may be expected from tailoring neuromodulation techniques to specific patient (neurocognitive) profiles.