Trial · NCT06679062
Suvorexant for Treatment of AUD and PTSD
NCT06679062, Phase 2, Recruiting, Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Suvorexant for Treatment of AUD and PTSD. Trials, record NCT06679062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06679062
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suvorexant for Treatment of AUD and PTSD
- NCT number
- NCT06679062
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 76 participants, estimated
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Conditions
- Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Insomnia
- Interventions
- Suvorexant, Placebo
- First posted
- 2024-11-07
- Last updated
- 2026-10-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Insomnia Severity Index (ISI) score from baseline to Day 14. | Baseline (Day 0) and Day 14 | The Insomnia Severity Index (ISI) is a brief questionnaire to screen for insomnia in participants. A scoring system is used to identify what degree insomnia (if any detected) is affecting daily life and sleep patterns. A total score is derived by summing all seven items with a total score ranging from 0 to 28 (with higher scores indicative of worse insomnia symptoms). |
| Secondary | Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14. | Baseline (Day 0) and Day 14 | The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving. |
| Secondary | Change in mean number of drinks per drinking day from baseline to Day 14. | Baseline (Day 0) and Day 14 | Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to calculate the number of drinks per day and drinks per drinking day over the course of the study period. |
| Secondary | Percent total days abstinent during the 14-day quit attempt period. | Baseline (Day 0) through Day 14 | Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the total number of abstinent days over the course of the study period. |
| Secondary | Change in the mean number of days abstinent during the medication period (day 0 through 14) compared to the 30-days prior (screening period). | Screening (30-days prior to baseline) and Baseline through Day 14 | Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the number of days with and without drinking from 30-days prior to baseline and 14-days post randomization. |
| Secondary | Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14. | Baseline (Day 0) through Day 14 | Gold-standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The symptom severity score ranges from 0 to 80 with higher score indicating worse PTSD symptoms. |
| Secondary | Change in PTSD score as measured by the PTSD Checklist for DSM-5 (PCL-5) from baseline to Day 14. | Baseline (Day 0) through Day 14 | The PCL-5 is a 20-item self-report measure that assesses DSM-5-based criteria for PTSD symptoms. Each item is rated on a 5-point Likert-type scale (0 = Not at all; 4 = Extremely) that indicates how much the participant has been bothered by an identified "worst" stressful event in the past month. The PTSD score ranges from 0 to 80 with higher score indication worse PTSD symptoms. |
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 |
|---|---|
| 41630040 | DERIVED |
Source PubMed
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.
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/NCT06679062
GET https://conductscience.org/api/trials/v1/NCT06679062/registered