Neurocognitive Empowerment for Addiction Treatment (NEAT) in Opioid Use Disorder and Amphetamine Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Neurocognitive Empowerment for Addiction Treatment (NEAT) in People With Opioid Use Disorder and Amphetamine Use Disorder: A Randomized Clinical Trial

Conditions
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Opioid-use Disorder, Amphetamine Use Disorders

Intervention / Treatment
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* Behavioral: Neurocognitive Empowerment for Addiction Treatment (NEAT)
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in an established substance use treatment program, such as the Women in Recovery or 12&12 programs, Oxford Houses or others to be identified in the region) and diagnosed with Opioid Use Disorder and/or Amphetamine Use Disorder based on DSM V criteria using MINI structured interview. Able to provide written informed consent. Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures. Completion of at least an 8th grade education, to help facilitate ability to engage in the written materials included in the NEAT program. Current mental or physical health symptoms that require immediate attention (such as suicidal ideation with intent or plan; active psychotic symptoms; delirium; etc.) Exclusion Criteria: Unwillingness or inability to complete any of the major aspects of the study protocol, including self-report or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task). Non-correctable vision or hearing problems. For individuals to complete the brain imaging portion of the project, the following additional exclusion criteria will be used: Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments. Current use of a medication or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study that could potentially affect brain functioning (e.g., stimulants, antidepressants, anxiolytics, antipsychotics, mood stabilizers, anti-hypertensives). Inclusion of individuals reporting other types of medications or supplements not listed or considered thus far will be at the discretion of the PI according to evidence in the literature of it affecting brain function or brain blood flow. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day). MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy. Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEAT Active Experimental Group<br>People in the active group will receive NEAT intervention | Behavioral: Neurocognitive Empowerment for Addiction Treatment (NEAT)<br>* 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).<br>|
| Active Comparator: Control Group<br>People in the control group will receive non-essential regularly-scheduled programming (active control) coinciding with the same timeframe | Behavioral: Active Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in craving self-report measured with Obsessive Compulsive Drug Use Scale (OCDUS) total score |  | From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive concerns self-report as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Concerns |  | From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Rehabilitation, Brain Rehabilitation, Treatment, Addiction, Heroin, Opiates, Meth, Methamphetamine