Brain Training for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Overseen ByJustin Anker, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neurotype Inc.
Disqualifiers: Pregnant, Neurological illness, Opioid use, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Bias Modification Biofeedback for opioid use disorder?
Research shows that neurofeedback, a component of Bias Modification Biofeedback, has been effective in reducing symptoms and cravings in opioid-dependent patients. Additionally, neurofeedback has shown benefits in improving impulsivity and attention deficits in individuals with substance use disorders, suggesting its potential usefulness in treating opioid use disorder.
12345Is brain training for opioid use disorder safe for humans?
Neurofeedback, a type of brain training, has been used safely in studies with people who have substance use disorders, including those dependent on opioids. These studies did not report any major safety concerns, suggesting that this treatment is generally safe for humans.
12467How does the Bias Modification Biofeedback treatment for opioid use disorder differ from other treatments?
Bias Modification Biofeedback is unique because it uses real-time feedback to help patients change their brain responses to drug-related cues, aiming to reduce cravings and prevent relapse. This approach is different from traditional treatments that often focus on medication or behavioral therapy alone, as it directly targets the brain's response patterns associated with addiction.
12368Eligibility Criteria
This trial is for individuals with Opioid Use Disorder (OUD) who are in treatment and can consent to follow-ups. Control participants must match an OUD patient by age and gender, have at least a 6th grade reading level, and no opioid or serious drug issues. Exclusions include pregnancy, inability to consent, poor vision for computer tasks, regular nicotine use within the past year, unwillingness to adjust hair for EEG headset application, or serious neurological conditions.Inclusion Criteria
I am receiving treatment for opioid use.
Exclusion Criteria
I have a serious neurological condition not caused by substance withdrawal.
I have a serious neurological condition.
Participant Groups
The study tests brain training games that aim to redirect attention away from drugs towards natural scenes. Participants' performance is linked with an EEG system that adjusts game difficulty based on their brain activity feedback during gameplay.
1Treatment groups
Experimental Treatment
Group I: BiofeedbackExperimental Treatment1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Minnesota - Department of Psychiatry & Behavioral HealthMinneapolis, MN
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Who is running the clinical trial?
Neurotype Inc.Lead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
University of MinnesotaCollaborator
References
Real-Time fMRI Neurofeedback in Patients With Tobacco Use Disorder During Smoking Cessation: Functional Differences and Implications of the First Training Session in Regard to Future Abstinence or Relapse. [2020]One of the most prominent symptoms in addiction disorders is the strong desire to consume a particular substance or to show a certain behavior (craving). The strong association between craving and the probability of relapse emphasizes the importance of craving in the therapeutic process. Former studies have demonstrated that neuromodulation using real-time fMRI (rtfMRI) neurofeedback (NF) can be used as a treatment modality in patients with tobacco use disorder. The aim of the present project was to determine whether it is possible to predict the outcome of NF training plus group psychotherapy at the beginning of the treatment. For that purpose, neuronal responses during the first rtfMRI NF session of patients who remained abstinent for at least 3 months were compared to those of patients with relapse. All patients were included in a certified smoke-free course and took part in three NF sessions. During the rtfMRI NF sessions tobacco-associated and neutral pictures were presented. Subjects were instructed to reduce their neuronal responses during the presentation of smoking cues in an individualized region of interest for craving [anterior cingulate cortex (ACC), insula or dorsolateral prefrontal cortex]. Patients were stratified to different groups [abstinence (N = 10) vs. relapse (N = 12)] according to their individual smoking status 3 months after the rtfMRI NF training. A direct comparison of BOLD responses during the first NF-session of patients who had remained abstinent over 3 months after the NF training and patients who had relapsed after 3 months showed that patients of the relapse group demonstrated enhanced BOLD responses, especially in the ACC, the supplementary motor area as well as dorsolateral prefrontal areas, compared to abstinent patients. These results suggest that there is a probability of estimating a successful withdrawal in patients with tobacco use disorder by analyzing the first rtfMRI NF session: a pronounced reduction of frontal responses during NF training in patients might be the functional correlate of better therapeutic success. The results of the first NF sessions could be useful as predictor whether a patient will be able to achieve success after the behavioral group therapy and NF training in quitting smoking or not.
Effectiveness of neurofeedback training as a treatment for opioid-dependent patients. [2022]Neurofeedback (NF) training has been employed as a therapeutic method in substance-dependence disorder over the last three decades. The purpose of the present study was to examine the effectiveness of this method on improvement of comorbid neuro-psychological syndromes in opioid-dependence disorder. Psychopathological and craving dimensions and brain activity signals of 20 opioid dependent patients were measured using Symptom Checklist-90-Revised (SCL-90-R), Heroin Craving Questionnaire (HCQ), and Quantitative Electroencephalography (QEEG). All the patients were undergoing pharmacotherapy. They were assigned to two groups that were matched based on SCL-90-R scores, education and age. The experimental group received 30 sessions of NF training in addition to their medicine. The control group received only the usual pharmacotherapy. The probable changes were monitored by reappraisal of all the patients after the treatment. We hypothesized that patients in the experimental group would show more reduction in their comorbid syndromes. The Multivariate Analysis of Covariance (MANCOVA) showed that the experimental group, in comparison with control group, showed significantly more improvement in all three outcome measures. In the SCL-90-R, improvement was noted with the hypochondriacs, obsession, interpersonal sensitivity, aggression, psychosis, and general symptomatic indexes. In the HCQ, improvement was found in the anticipation of positive outcome, desire to use substance, and total average score. Finally, the QEEG showed positive changes in frontal, central and parietal delta, frontal and central theta, parietal alpha and frontal and central Sensory Motor Rhythm (SMR) amplitudes. This study suggests that NF can be used as a therapeutic method to ameliorate abnormalities related to opioid-dependence disorders. The results emphasize the importance of neuropsychological interventions in treatment of substance-dependence disorders.
Mindfulness-Oriented Recovery Enhancement remediates hedonic dysregulation in opioid users: Neural and affective evidence of target engagement. [2020]Addiction neuroscience models posit that recurrent drug use increases reactivity to drug-related cues and blunts responsiveness to natural rewards, propelling a cycle of hedonic dysregulation that drives addictive behavior. Here, we assessed whether a cognitive intervention for addiction, Mindfulness-Oriented Recovery Enhancement (MORE), could restructure reward responsiveness from valuation of drug-related reward back to valuation of natural reward. Before and after 8 weeks of MORE or a support group control, prescription opioid users (N = 135) viewed opioid and natural reward cues while an electroencephalogram biomarker of target engagement was assessed. MORE was associated with decreased opioid cue-reactivity and enhanced capacity to regulate responses to opioid and natural reward cues. Increased positive affective responses to natural reward cues were associated with decreased craving and mediated MORE's therapeutic effects on opioid misuse. This series of randomized experiments provide the first neurophysiological evidence that an integrative behavioral treatment can remediate hedonic dysregulation among chronic opioid users.
Benefits of EEG-Neurofeedback on the Modulation of Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates: A Pilot Study. [2021]The aim of this pilot study was to assess whether neurofeedback (NFB) can be useful in the treatment of impulsive behavior in long-term abstinent cocaine and heroin addicts. A single-blind sham-controlled NFB protocol was carried out to assess the effects of NFB on impulsivity in 20 (10 + 10) cocaine and heroin long-term abstinent addicts (Diagnostic and Statistical Manual of Mental Disorders [4th ed., text rev.; DSM-IV-TR]). Psychotic and neurologic diseases were excluded. Participants underwent 40 NFB sessions based on the very slow cortical potential range. Inhibitory deficits were specifically addressed through right and left prefrontal training. Clinical improvement was measured with Likert-type scales, the Hamilton Depression Rating Scale, and the State-Trait Anxiety Inventory, and impulsivity was assessed using the Barratt Impulsiveness Scale and the Continuous Performance Test. Although the results are preliminary due to the small sample size, the NFB-treated group showed a significant clinical improvement, including symptoms of anxiety and depression, with two differentiated time periods. No significant clinical improvement was found in the control group. A significant decrease in the post- versus pre-treatment measures of global impulsivity, nonplanning impulsivity, and error commission measures was found in the NFB-treated group; effect size (dKorr) in the pre-post control design was moderate. No significant change was found in the control group. Despite the limitations of this study, the results suggest that NFB is better than placebo in improving impulsivity and clinical symptoms of anxiety and depression in long-term abstinent cocaine- and heroin-dependent individuals.
An assessment of an automated EEG biofeedback system for attention deficits in a substance use disorders residential treatment setting. [2022]Attention deficits are prevalent among individuals with substance use disorders and may interfere with recovery. The present study evaluated the effectiveness of an automated electroencephalogram (EEG) biofeedback system in recovering illicit substance users who had attention deficits upon admission to a comprehensive residential treatment facility. All participants (n = 95) received group, family, and individual counseling. Participants were randomly assigned to 1 of 3 groups that either received 15 sessions of automated EEG biofeedback (AEB), 15 sessions of clinician guided EEG biofeedback (CEB), or 15 additional therapy sessions (AT). For the AEB and CEB groups, operant contingencies reinforced EEG frequencies in the 15-18 Hz (β) and 12-15 Hz (sensorimotor rhythm, "SMR") ranges and reduce low frequencies in the 1-12 Hz (Δ, θ, and α) and 22-30 Hz (high β) ranges. The Test of Variables of Attention (TOVA), a "Go-NoGo" task, was the outcome measure. Attention scores did not change on any TOVA measure in the AT group. Reaction time variability, omission errors, commission errors, and d' improved significantly (all p values
Neuroimaging the Effectiveness of Substance Use Disorder Treatments. [2023]Neuroimaging techniques to measure the function and biochemistry of the human brain such as positron emission tomography (PET), proton magnetic resonance spectroscopy ((1)H MRS), and functional magnetic resonance imaging (fMRI), are powerful tools for assessing neurobiological mechanisms underlying the response to treatments in substance use disorders. Here, we review the neuroimaging literature on pharmacological and behavioral treatment in substance use disorder. We focus on neural effects of medications that reduce craving (e.g., naltrexone, bupropion hydrochloride, baclofen, methadone, varenicline) and that improve cognitive control (e.g., modafinil, N-acetylcysteine), of behavioral treatments for substance use disorders (e.g., cognitive bias modification training, virtual reality, motivational interventions) and neuromodulatory interventions such as neurofeedback and transcranial magnetic stimulation. A consistent finding for the effectiveness of therapeutic interventions identifies the improvement of executive control networks and the dampening of limbic activation, highlighting their values as targets for therapeutic interventions in substance use disorders.
Integrating cognitive bias modification for pain and opioid cues into medication for opioid use disorder clinical care: Feasibility, acceptability, and preliminary results. [2023]Despite high co-occurrence, chronic pain is often unaddressed in treatment for opioid use disorder (OUD) and little is known about mechanisms that may underlie associations between pain and opioid use. Using an attentional bias (AB) task with both pain and opioid cues, we evaluated a cognitive bias modification (CBM) task administered during regularly scheduled medications for OUD (mOUD) dosing visits. The current study evaluated the feasibility, acceptability, and preliminary efficacy of the CBM task. Outcomes for AB tasks used traditional mean-based score and trial-level bias scores (TLBS).
Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. [2022]Relapse after initially successful treatment is a significant problem facing the treatment of opioid dependence. Evidence suggests craving elicited by re-exposure to drug cues may precipitate relapse. Attempts to identify neural biomarkers of cue-elicited craving have yielded inconsistent findings. We aimed to apply a novel continuous functional magnetic resonance imaging technique to follow the minute-to-minute evolution of brain responses, which correlate with the waxing and waning of craving. Newly detoxified male opioid-dependent patients and healthy control participants attended two separate, counterbalanced, functional magnetic resonance imaging scanning sessions during which they viewed a 10-minute video (drug cue or neutral cue) followed by 5 minutes of fixation. Participants rated the intensity of their craving throughout each session. We hypothesized that subcortical/ventral prefrontal cortex (PFC) regions and dorsal PFC regions would show different associations with craving reflecting their putative roles in appetitive processing versus cognitive control. Compared with controls, drug cue (minus neutral cue) video recruited the left amygdala and was temporally correlated with craving. In contrast, dorsal anterior cingulate blood-oxygen-level-dependent signal time course was higher than controls only during a period after cue exposure when craving levels were declining. Against expectations, neither the ventral striatum nor ventral PFC was significantly recruited by drug cue exposure. Findings suggest that the amygdala has a central role in craving, whereas the dorsal anterior cingulate may control craving in treatment-seeking patients. Time course analysis yielded new insights into the neural substrates of craving that could objectively validate development of psychological and pharmacological approaches to sustained abstinence.