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NCT05086835 · ClinicalTrials.gov registry record · NA
A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders
A NA study, sponsored by Mclean Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05086835 is a NA study that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 10 participants.
The verdict
NCT05086835, a NA study, was terminated before completion, sponsored by Mclean Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for OUD, thus, the development of new interventions to reduce craving is a priority for addressing the opioid crisis (NIH HEAL Initiative Research Plan, 2019). Deficits in executive functioning, particularly working memory, are a central mechanism that undermines the ability to inhibit craving. Laboratory studies in non-clinical samples show that engaging in working memory tasks before or during a craving induction increases the ability to resist craving. This suggests that people with OUD may benefit from engaging in working memory tasks at the specific moment when craving occurs. Although previous research shows that working memory "training" does not improve clinical outcomes in OUD, these studies have not delivered training at the moment that craving actually occurs in daily life. Thus, engaging in working memory tasks at the moment that craving occurs could presumably help individuals with OUD to manage this persistent symptom, but this has not been tested. Further, studies using Ecological Momentary Assessment (EMA) methods show that people with OUD can accurately track moment-to-moment fluctuations in craving in their daily lives, suggesting that it may be feasible to deliver interventions for craving in the moment when craving is reported. This study will test the efficacy of embedding a mobile cognitive intervention into an EMA design in people with OUD. Using the NIH Stage Model of Intervention Development, Stage 1A of this project will optimize a working memory intervention based on iterative feedback from a sample of people with OUD (n = 20), in preparation for a Stage 1B trial using a randomized design. In this trial, participants with OUDs (n = 60) will complet
Interventions
- OTHER Working Memory Task
- OTHER Visual Search Task
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2022-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05086835
The ClinicalTrials.gov registry entry for NCT05086835 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Working Memory Task is the first listed.
NCT05086835 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05086835 about?
NCT05086835 is a clinical study titled "A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders". Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for O...
What is the current status of trial NCT05086835?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2021-10-14. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT05086835?
The interventions under investigation include: Working Memory Task (OTHER), Visual Search Task (OTHER).
Who is sponsoring clinical trial NCT05086835?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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