Trial · NCT05458609
Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
NCT05458609, Phase 3, Completed, Baylor College of Medicine
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep. Trials, record NCT05458609. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05458609
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
- NCT number
- NCT05458609
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Alcohol Use Disorder
- Interventions
- Lemborexant 10 mg, Naltrexone
- First posted
- 2022-07-14
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cue-induced Alcohol Cravings Using the Alcohol Urge Questionnaire | Baseline to last available post-baseline assessment (2 to 4 weeks after randomization) | Alcohol Urge Questionnaire (AUQ) total score (range 8-56; higher scores indicate greater craving) was assessed following alcohol-related virtual reality cue exposure at baseline and at multiple post-baseline time points during treatment. For this outcome, change from baseline to the last available post-baseline AUQ assessment was calculated and reported as a single summary value. |
| Primary | Non-Cued Alcohol Cravings Using the Penn Alcohol Craving Scale | Baseline to study endpoint (2 to 4 weeks after randomization) | Penn Alcohol Craving Scale (PACS): The Penn Alcohol Craving Scale is a 5-item self-report questionnaire assessing alcohol craving over the prior week. Total scores range from 0 to 30, with higher scores indicating greater alcohol craving. PACS assessments were obtained at baseline and weekly during the treatment period. For this outcome, change from baseline to the endpoint PACS assessment was calculated and reported as a single summary value. |
| Secondary | Actigraphy to Measure Total Sleep Time | Baseline to study endpoint (2 to 4 weeks after randomization) | The ActiGraph wGT3X-BT will measure daily total sleep time (hours) |
| Secondary | Actigraphy to Measure Total Awakenings After Sleep Onset During the Study Period | Baseline to study endpoint (2 to 4 weeks after randomization) | The ActiGraph wGT3X-BT will measure total number of awakenings after sleep onset during the study period |
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.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05458609
GET https://conductscience.org/api/trials/v1/NCT05458609/registered