💬In plain words
What the trial is, and whether it could suit you
The research study is being conducted to better understand memory function in people with opioid use disorder (OUD) and whether memory training can improve the symptoms and lives of people with OUD. Further, this study seeks to identify how brain and heart activity contribute to memory function and OUD symptoms. Participants will be asked to complete a baseline assessment, four weeks of at-home memory training (MemFlex), and a post-treatment follow-up assessment. Everyone enrolled will receive MemFlex as there is no placebo group. Each visit will include collection of a urine sample for drug testing. During the baseline and follow-up assessments, researchers will collect brain information using functional near-infrared spectroscopy (fNIRS) and heartbeat data using a wearable wristband sensor. MemFlex is a cognitive-behavioral intervention that does not pose any risk. However, the use of
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age 18 years to 60 years old.
2. Willingness to provide signed, informed consent and commit to completing study procedures
3. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, and must have access to a cellphone.
4. OUD subjects: Lifetime self-reported history of OUD (according to DSM-5 criteria)
5. OUD subjects: On a stable dose (at least 2 weeks without change) of MOUD (e.g., buprenorphine, methadone) as confirmed by self-report, urine drug screening, and/or the Prescription Drug Monitoring Program database.
6. OUD subjects: Access to a stable residence or space to complete the at-home treatment module
Exclusion Criteria:
1. Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) determined by self-reported history or physical exam and disorder deemed by PI to significantly interfere with brain function or make the study hazardous for the subject.
2. Head trauma or injury deemed by PI as likely to impact the prefrontal cortex (e.g., loss of consciousness for more than 30 minutes or skull fracture, intracranial bleeding, or abnormal MRI) as determined by self-reported history or physical exam.
3. Medical condition or medical treatment that may interfere with the subject's ability to complete the intervention, at discretion of the PI (e.g., extended surgery planned or expecting to give birth during the course of the study)
4. Inability to sit upright while remaining relatively still and operating a mouse and keypad.
5. Current ongoing participation in a research study or participation in a clinical trial and receipt of investigational drug(s) or intervention during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
6. Currently prescribed opioid medication for treatment of pain or other disorder (besides opioid use disorder).
7. OUD subjects: Past 1-year history of non-OUD substance use disorder (other than nicotine, alcohol, or cannabis use disorders).
8. OUD subjects: Positive urine drug screen for any tested substances except for opioids, cocaine, and cannabis at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).
9. HC subjects: Lifetime history of any substance use disorder (other than nicotine use disorder at any time and alcohol or cannabis use disorders more than 1 year ago).
10. HC subjects: Positive urine drug screen for any tested substances at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).
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