Opioid-use Disorder Clinical Trial
Official title:
Neurocognitive Empowerment for Addiction Treatment (NEAT) in People With Opioid Use Disorder and Amphetamine Use Disorder: A Randomized Clinical Trial
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Completed |
NCT04505540 -
Start Treatment and Recovery for Opioid Use Disorder
|
N/A | |
Completed |
NCT03065049 -
Transforming Recovery Through Exercise and Community
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Suspended |
NCT05001789 -
Cognitive Functioning in Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04650386 -
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
|
N/A | |
Completed |
NCT03715634 -
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
|
Phase 1 | |
Enrolling by invitation |
NCT04991974 -
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
|
Phase 2/Phase 3 | |
Completed |
NCT04122755 -
Single Ascending Dose Study of ALA-1000
|
Phase 1 | |
Recruiting |
NCT05049460 -
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
|
N/A | |
Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
Recruiting |
NCT05028998 -
COVID-19-Related Opioid Treatment Policy Evaluation
|
||
Completed |
NCT05047627 -
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04129580 -
reSET-O RCT (Randomized Controlled Trial)
|
N/A | |
Recruiting |
NCT03923374 -
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
|
||
Completed |
NCT04464421 -
SMART Effectiveness Trial
|
N/A | |
Suspended |
NCT02687360 -
Imaging the Effects of rTMS on Chronic Pain
|
N/A | |
Completed |
NCT04056182 -
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
|
Phase 2 |