NCT06643988 Autobiographical Memory in Opioid Use Disorder
| NCT ID | NCT06643988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-08-19 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 MemFlex in this study is experimental as it has not been tested in individuals with OUD. We will enroll 20 participants with OUD and 10 participants meeting healthy volunteer criteria.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06643988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06643988 currently recruiting?
Yes, NCT06643988 is actively recruiting participants. Contact the research team at megan.ivey@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06643988 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06643988 clinical trial?
NCT06643988 is sponsored by University of Pennsylvania. The trial plans to enroll 30 participants.