MemFlex for Opioid Use Disorder

(NAMO Trial)

Overseen By Megan Ivey, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: MOUD

Must not be taking: Opioid pain medication

Disqualifiers: Severe psychiatric, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. However, if you are on a stable dose of medication for opioid use disorder (like buprenorphine or methadone), you can continue taking it. If you are currently prescribed opioid medication for pain or other disorders, you cannot participate in the trial.

What makes the drug MemFlex unique for treating opioid use disorder?

MemFlex, which includes memantine, is unique because it is being studied as an addition to existing treatments like buprenorphine, potentially offering a new approach to reduce relapse rates in young adults with opioid use disorder. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with opioid use disorder (OUD) who are interested in participating in a study to improve memory function. Participants will undergo drug testing and must be willing to complete at-home memory training and assessments involving brain and heart activity monitoring.

Inclusion Criteria

I have been on a stable dose of medication for opioid use disorder for at least 2 weeks.

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

OUD subjects must have a lifetime self-reported history of OUD (according to DSM-5 criteria)

Exclusion Criteria

I am currently taking opioid medication for pain or another condition.

HC subjects must not have a positive urine drug screen for any tested substances at screening or the baseline assessment visit (a test may be repeated if needed to confirm accuracy)

Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) conditions determined by self-reported history or physical exam and deemed by PI to significantly interfere with brain function or make the study hazardous for the subject

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including fNIRS and heartbeat data collection

1 week

1 visit (in-person)

Treatment

Participants undergo four weeks of at-home memory training (MemFlex)

4 weeks

At-home sessions

Post-treatment Follow-up

Participants complete a follow-up assessment including fNIRS and heartbeat data collection

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MemFlex

Trial Overview The intervention being tested is MemFlex, a cognitive-behavioral therapy aimed at improving symptoms of OUD through memory training. All participants will receive this intervention without the comparison of a placebo group.

Participant Groups

Group I: OUD Experimental Treatment 1 Intervention

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.

Group II: Healthy controls Active Control 1 Intervention

Participants who meet criteria as healthy volunteers, will receive no MemFlex training but will undergo assessments as well as fNIRS computerized tasks.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Medication-Assisted Treatment (MAT) for opioid use disorder shows mixed effects on functional outcomes, with some studies indicating poorer cognitive performance, such as working memory and cognitive speed, compared to healthy controls.

While MAT users may experience lower fatigue rates with buprenorphine compared to methadone, the overall quality of evidence regarding functional outcomes is low, highlighting the need for more rigorous studies to draw stronger conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review. Maglione, MA., Raaen, L., Chen, C., et al.[2019]

Over 2 million Americans have opioid use disorder, which is partly due to overprescribing, highlighting the need for better opioid stewardship and management strategies by physicians.

Three FDA-approved medications—methadone, buprenorphine, and naltrexone—are effective for treating opioid use disorder, but successful outcomes are best achieved through comprehensive, interprofessional management plans rather than relying solely on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug and Alcohol Use Disorders: Opioid Use Disorder. Witt, L., Butler, F.[2019]

Medications like methadone, buprenorphine, and extended-release naltrexone are effective in improving outcomes for individuals with opioid use disorder, but their effectiveness is often hindered by challenges in diagnosis, treatment entry, and retention.

There is a critical need to enhance the use of these medications through better training for healthcare professionals and the development of new treatment models to provide personalized care for those affected by opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of opioid use disorder in the USA: present status and future directions. Blanco, C., Volkow, ND.[2019]

Methadone and buprenorphine-naloxone are effective long-term maintenance medications for opioid use disorders (OUDs), positively impacting the health of individuals with opioid addiction.

Despite their effectiveness, the use of buprenorphine and naltrexone is limited due to stigma and barriers in access to treatment, highlighting the need for improved education and resources in the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of opioid addiction treatment and related preclinical research. Kreek, MJ., Reed, B., Butelman, ER.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Prescription Drug and Alcohol Use Disorders: Opioid Use Disorder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Management of opioid use disorder in the USA: present status and future directions. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Memantine improves buprenorphine/naloxone treatment for opioid dependent young adults. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Current status of opioid addiction treatment and related preclinical research. [2023]