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.
Condition or disease | Intervention/treatment | Phase |
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Opioid-use Disorder Amphetamine Use Disorders | Behavioral: Neurocognitive Empowerment for Addiction Treatment (NEAT) Behavioral: Active Control | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neurocognitive Empowerment for Addiction Treatment (NEAT) in People With Opioid Use Disorder and Amphetamine Use Disorder: A Randomized Clinical Trial |
Actual Study Start Date : | March 6, 2019 |
Estimated Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | March 1, 2023 |
Arm | Intervention/treatment |
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Experimental: NEAT Active Experimental Group
People in the active group will receive NEAT intervention
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Behavioral: Neurocognitive Empowerment for Addiction Treatment (NEAT)
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).
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Active Comparator: Control Group
People in the control group will receive non-essential regularly-scheduled programming (active control) coinciding with the same timeframe
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Behavioral: Active Control
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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
For individuals to complete the brain imaging portion of the project, the following additional exclusion criteria will be used:
Contact: Brionne Sawyer-Fed | 918-504-9675 | bsawyer@laureateinstitute.org |
United States, Oklahoma | |
Laureate Institute for Brain Research | Recruiting |
Tulsa, Oklahoma, United States, 74136 | |
Contact: Colleen McCallum, MBA 918-502-5180 cmccallum@libr.net | |
Principal Investigator: Hamed Ekhtiari, MD, PhD | |
Sub-Investigator: Robin L Aupperle, PhD |
Tracking Information | |||||
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First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | April 22, 2019 | ||||
Last Update Posted Date | August 7, 2020 | ||||
Actual Study Start Date ICMJE | March 6, 2019 | ||||
Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in craving self-report measured with Obsessive Compulsive Drug Use Scale (OCDUS) total score [ Time Frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment) ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Change in cognitive concerns self-report as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Concerns [ Time Frame: From pre to post intervention (4 weeks following last intervention session, on average at 18 weeks after baseline assessment) ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Neurocognitive Empowerment for Addiction Treatment (NEAT) in Opioid Use Disorder and Amphetamine Use Disorder | ||||
Official Title ICMJE | Neurocognitive Empowerment for Addiction Treatment (NEAT) in People With Opioid Use Disorder and Amphetamine Use Disorder: A Randomized Clinical Trial | ||||
Brief Summary |
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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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ekhtiari H, Rezapour T, Sawyer B, Yeh HW, Kuplicki R, Tarrasch M, Paulus MP, Aupperle R. Neurocognitive Empowerment for Addiction Treatment (NEAT): study protocol for a randomized controlled trial. Trials. 2021 May 7;22(1):330. doi: 10.1186/s13063-021-05268-8. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 1, 2023 | ||||
Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
For individuals to complete the brain imaging portion of the project, the following additional exclusion criteria will be used:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03922646 | ||||
Other Study ID Numbers ICMJE | 2018-007 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Laureate Institute for Brain Research, Inc. | ||||
Study Sponsor ICMJE | Laureate Institute for Brain Research, Inc. | ||||
Collaborators ICMJE | Oklahoma Center for the Advancement of Science and Technology | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Laureate Institute for Brain Research, Inc. | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |