Autobiographical Memory in Opioid Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06643988
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • MemFlex — BEHAVIORAL
    MemFlex employs cognitive training exercises in self-led sessions to improve 1) switching between specific and general AMs, 2) access to positive AMs, and 3) vividness of positive AMs.

Study Details

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.

Key Dates

First listed
Oct 16, 2024
Start date
Aug 19, 2025
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Healthy controls
    Participants who meet criteria as healthy volunteers, will receive no MemFlex training but will undergo assessments as well as fNIRS computerized tasks.
  • Experimental: OUD
    Participants who meet criteria for OUD and are on a stable dose of medication assisted therapy for OUD will be trained in memory flexibility training (MemFlex) - cognitive training exercises.

Primary Outcome Measure

Autobiographical Memory (AM) Recall (AMT-AI) [ Time Frame: Pre and Post treatment assessment (weeks 1 and 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Megan Ivey, MS
[email protected]
215-746-7712
Anna Rose Childress, PhD (PRINCIPAL_INVESTIGATOR)
Nathan Hager, PhD (SUB_INVESTIGATOR)

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