Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
NCT Number: NCT03922646
Chronic drug addiction is not only associated with increased mental health symptoms, such as anxiety and depression, but also with brain (neural and cognitive) deficits. These neurocognitive deficits (NCDs) in memory, attention, decision-making, self-control and judgement disturb normal daily functioning and attempts for abstinence. These NCDs are also associated with worse long-term treatment outcomes. Current treatment programs for addiction to opioids and amphetamines are mainly focused on abstinence from illicit drugs with or without assistance of medications, with the assumption that these NCDs will subsequently heal. However, NCDs are found to persist even after a long-term abstinence and are thought to contribute to relapse, decreases quality of life, or lack of reintegration into society. Furthermore, NCDs (particularly related to attention and memory) are considered a potential obstacle for engagement in therapy services for addiction and associated mood, anxiety and trauma-related comorbidities (i.e., cognitive-behavioral therapies). Brain rehabilitation programs focused on compensatory strategies and training exercises for NCDs associated with traumatic brain injuries, stroke, multiple sclerosis and schizophrenia has consistently been found to improve functioning and long-term outcomes for these populations. There have been a few preliminary attempts to transplant cognitive rehabilitation with substance use populations, with some limited promise. However, these previous studies failed to link cognitive strategies with the drug use and affective/craving symptoms experienced by patients and also did not fully incorporate knowledge gained from neuroscientific research on opioid and/or methamphetamine addiction specifically.
The aim of this study is to characterize clinical efficacy for an intervention targeting NCDs in opioid and/or methamphetamine addiction by enhancing awareness and use of neurocognitive skills in the context of substance use recovery. This aim will be accomplished by randomizing 80 subjects with opioid and/or methamphetamine use disorder who are already enrolled in substance use treatment in the state of Oklahoma to also complete a novel "Neurocognitive Empowerment for Addiction Treatment" (NEAT) program developed by a group of investigators at Laureate Institute for Brain Research, Tulsa, Oklahoma. NEAT will be novel in (a) its use of cartoons, brain awareness games and real-life scenarios to ensure it is interactive and engaging, (b) the focus on the role of neurocognitive deficits in recovery from substance use and co-occurring mental health symptomatology, and (c) its incorporation of neuroscientific findings specific to substance use to the training and exercise strategies. Subjects will be followed up for twelve months after starting the program with different measures for addiction and mental health recovery to explore the efficacy of NEAT compared to the control intervention. Using LIBR's cutting-edge neuroimaging facilities before and after interventions, this study has the unique opportunity to monitor not only clinical outcomes but also potential changes NEAT may have on brain structure and function. In case of finding reasonable clinical efficacy for NEAT, it will be hopefully integrated as a manualized brain rehabilitation program to the substance use treatment programs.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Tulsa, Oklahoma, 74136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For individuals to complete the brain imaging portion of the project, the following additional exclusion criteria will be used:
NEAT will be conducted in person, in groups of 6-14, and consist of 14, 1.5-hour sessions. Each NEAT session will consist of (1) a didactic, psychoeducation portion describing the concepts and skills of focus, (2) written material with descriptions of the concepts/skills in verbal and pictorial (cartoon) formats, (3) practicing with cognitive tasks relevant for each skill, (4) discussion of how they can monitor and practice each skill in their daily life. Specifically, we will provide psychoeducation, cognitive exercises, time-management and daily practice focused on domains of attention (focused and divided attention; attentional biases), memory (declarative, prospective, emotional memory), flexibility and inhibition, and problem-solving. Each session will discuss the relevance of these functions for the recovery from drug addiction and for managing affective/motivational symptoms commonly related to substance use (i.e., craving, anxiety, depression, trauma).
The active control intervention will be composed of active, but non-essential aspects of the larger treatment program (i.e., those that treatment programs do not believe are necessary or central to their program, for example, art classes, exercise classes, chore time, or extra 12 steps meetings). This will ensure that subjects are not being prevented from accessing treatment that is already known to be helpful in substance use recovery, that the active control condition and NEAT intervention have equivalent credibility and expectancies, and optimizing the generalizability of findings.
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Desire for Drug Questionnaire (DDQ) has two subscores "desire and intention" (DI) and "negative reinforcement" (NR) subscores of the (Franken, et al., 2002).
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
UPPS (Urgency, Remediation, Perseverance, and Sensation Seeking) assesses an additional personality pathway to impulsive behavior, Positive Urgency, in addition to the four pathways assessed in the original version of the scale-- Urgency (now Negative Urgency), (lack of) Premeditation, (lack of) Perseverance, and Sensation Seeking.
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment)
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
Drug Cue Reactivity BOLD Signal is measured as average blood oxygen level dependent (BOLD) signal difference with voxel-wise analysis in the regions of interests (ROIs) (prefrontal cortex segments, cingulate cortex, insula segments, striatum nuclei, thalamus nuclei and extended amygdala nuclei) in craving > neutral contrast in drug cue exposure fMRI task with blocks of neutral and drug related images
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
Cortical-subcortical task-based connectivity in cue exposure fMRI is measured as psychophysiological interaction (PPI) between average blood oxygen level dependent (BOLD) signal time series in subcortical ROIs (seeds) and voxels within prefrontal cortex and insula, using craving > neutral contrast regressor
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
Cortical-Subcortical Connectivity is measured as correlation between resting-state average blood oxygen level dependent (BOLD) signal time series in subcortical ROIs (seeds) and voxels within prefrontal cortex and Insula
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
Time frame: From pre to post intervention (6 weeks following last intervention session, on average at 20 weeks after baseline assessment)
NIH toolbox: cognition includes 9 different tests: Picture Sequence Memory Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Oral Reading Recognition Test, Dimensional Change Card Sort Test, Pattern Comparison Processing Speed Test, Auditory Verbal Learning Test (Rey), Oral Symbol Digit Test. We will make a composite score using the first principal component analysis (PCA) to have one single representation of neuropsychological functioning
Time frame: during intervention, 3 months, 6 months and 12 months after the intervention
Urine drug tests for illicit drugs collected in a weekly basis summed up together during intervention, 3 months, 6 months and 12 months after the intervention
Laureate Institute for Brain Research, Inc.
Other
Neurocognitive Empowerment for Addiction Treatment (NEAT) in People With Opioid Use Disorder and Amphetamine Use Disorder: A Randomized Clinical Trial
Acronym: NEAT
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