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NCT04132609 · ClinicalTrials.gov registry record · NA
Opioid and Pain Cognition
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04132609: Completed NA study, sponsored by Yale University.
NCT04132609 is a NA study that has completed, run by Yale University. The registered enrollment target is 20 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
NCT04132609, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The proposed research will provide foundational research to develop this low-burden behavioral intervention that can potentially improve outcomes of OUD. The Specific Aims of the proposal include conducting a pilot randomized controlled trial with post-intervention and 3 month follow up to evaluate feasibility, acceptability, and preliminary effectiveness of CBM task for opioid and pain cues (Aim 1), examine naturalistic assessment of opioid craving and pain intensity/interference (Aim 2), and conduct qualitative analysis of Veterans experiences of adjunctive treatment in MAT clinic and perceptions of CBM as an intervention (Aim 3). Male and female Veterans meeting DSM5 criteria for OUD (N=60) currently on MAT will be randomly assigned to 4 weeks of CBM for opioid and pain cues or control (standard attentional bias). CBM/control tasks will be administered during weekly MAT clinic appointments and opioid craving and pain intensity/interference will be randomly assessed during the day using a mobile device. Post-intervention, Veterans will be invited to participate in a digitally recorded semi-structured interview for qualitative assessment of CBM and treatment adjunctive to MAT. MAT outcomes (urine toxicology screens, MAT appointments) will also be measured at 3-month follow up. The current study will elucidate dynamic relationships between attention to opioid and pain cues and whether modifying attention can reduce risk factors associated with treatment failure. If successful, with its low patient and provider burden, CBM could be readily incorporated in research and clinical practice as an adjunctive treatment for OUD.
Primary Outcome
The treatment-related adverse events will be measured as the number of participants assessed by cognitive behavior modification using an eprime task to compare the number of correct answers.
Interventions
- BEHAVIORAL Cognitive bias modification
- BEHAVIORAL Standard attentional bias
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2021-03-01 |
| Phase | NA |
What the finished NCT04132609 record still lists
NCT04132609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 Cognitive bias modification is the first listed.
NCT04132609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04132609 about?
NCT04132609 is a clinical study titled "Opioid and Pain Cognition". The proposed research will provide foundational research to develop this low-burden behavioral intervention that can potentially improve outcomes of OUD. The Specific Aims of the proposal include conducting a pilot randomized controlled trial with post-intervention and 3 month follow up to evaluate ...
What is the current status of trial NCT04132609?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-02-01. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT04132609?
The interventions under investigation include: Cognitive bias modification (BEHAVIORAL), Standard attentional bias (BEHAVIORAL).
Who is sponsoring clinical trial NCT04132609?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04132609's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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