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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 is a NA study that has completed, run by Yale University. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04132609
The ClinicalTrials.gov registry entry for NCT04132609 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive bias modification is the first listed.
NCT04132609 reports 0 study locations.
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.
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