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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: Clinical Trial NA study, sponsored by Mclean Hospital.
NCT05086835 is a NA study that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A single-item craving measure adapted from the 3-Item Craving Scale (Weiss et al., 2003).
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 |
Why NCT05086835 stopped before completion
NCT05086835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Working Memory Task is the first listed.
NCT05086835 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05086835's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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