Trial · NCT06981195
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
NCT06981195, Phase 2, Recruiting, Virginia Commonwealth University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects. Trials, record NCT06981195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06981195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
- NCT number
- NCT06981195
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Opioid Use Disorder, Opioid Use, Insomnia, Orexin Antagonist
- Interventions
- Placebo, Lemborexant 10 MG
- First posted
- 2025-05-20
- Last updated
- 2026-07-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia | from baseline to end of 8-week treatment | Insomnia Severity Index will be used for assessing insomnia related symptoms. Scores on this measure range from 0-28, with higher scores indicating greater symptoms. Mean ISI score per group at baseline and at the end of 8-week treatment will be reported. |
| Primary | Impulsivity | from baseline to end of 8-week treatment | Impulsive responding will be measured by performance on the 5-trial adjusting delay discounting task, with the outcome being a derived discounting rate. Mean delay discounting rate per group at baseline and at the end of 8-week treatment will be reported. |
| Secondary | Insomnia related daily sleep metrics: Total sleep time (TST) | from baseline to end of 8-week treatment | Total sleep time (TST) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived TST score per group at baseline and end of 8-week treatment will be reported. |
| Secondary | Insomnia related daily sleep metrics: Wake After Sleep Onset (WASO) | from baseline to end of 8-week treatment | Wake After Sleep Onset (WASO), will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived WASO score per group at baseline and end of 8-week treatment will be reported. |
| Secondary | Insomnia related daily sleep metrics: Sleep efficiency (SE) | from baseline to end of 8-week treatment | Sleep efficiency (SE) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SE score per group at baseline and end of 8-week treatment will be reported. |
| Secondary | Insomnia related daily sleep metrics: Sleep onset latency (SOL) | from baseline to end of 8-week treatment | Sleep onset latency (SOL) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SOL score per group at baseline and end of 8-week treatment will be reported. |
| Secondary | Negative Emotionality: Distress Tolerance Scale (DTS) | from baseline to end of 8-week treatment | The Distress Tolerance Scale will be used as a measure of negative emotionality. The DTS is a 15-item, 5-point Likert scale measure with item scores ranging from 1-5. Lower scores indicate greater distress tolerance. Mean DTS score per group at baseline and at the end of 8-week treatment will be reported. |
| Secondary | Negative Emotionality: Patient Health Questionnaire (PHQ-9) | from baseline to end of 8-week treatment | The PHQ-9 is a brief (9-item) measure of depressive symptoms. Scores range from 1-27, with higher scores indicating greater severity of depressive symptoms. Mean PHQ-9 score per group at baseline and at the end of 8-week treatment will be reported. |
| Secondary | Negative Emotionality: General Anxiety Disorder (GAD-7) | from baseline to end of 8-week treatment | The GAD-7 is a brief (7-item) measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater severity of anxiety symptoms. Mean GAD-7 score per group at baseline and at the end of 8-week treatment will be reported. |
| Secondary | Metacognition: Metacognitions Questionnaire (MCQ-30) | from baseline to end of 8-week treatment | The MCQ-30 a brief (30-item) measure of metacognition. Total scores range from 30-120, with higher scores indicating greater magnitude of problematic metacognitions. Mean MCQ-30 score per group at baseline and at the end of 8-week treatment will be reported. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41151943 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA059483 | Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia | MARTIN, CAITLIN EILEEN | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2024 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Delay Discounting | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06981195
GET https://conductscience.org/api/trials/v1/NCT06981195/registered