Phase 2 PTSD Trial, Recruiting NCT06679062 Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance Condition: PTSD
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Phase 2 PTSD Trial, Recruiting

NCT06679062
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 21 and 65 years old.
  • You have been diagnosed with moderate or severe Alcohol Use Disorder (a problematic pattern of heavy drinking) within the past 12 months.
  • You are currently experiencing PTSD symptoms above a certain level, as measured by a standard questionnaire.
  • You personally want to cut down or stop drinking within the next 6 months, and you want to receive treatment for PTSD.
  • You are experiencing at least some sleep problems, as shown by a score of 7 or higher on a standard sleep questionnaire.
  • You are willing to stop taking all other sleep medications for the duration of the study.
  • You have had stable housing for the 2 weeks before the study starts and do not expect to lose your housing within the next month.

Who may not be able to join:

  • You have been diagnosed in the past 12 months with a moderate or severe addiction to substances other than alcohol, nicotine, or marijuana.
  • You have ever been diagnosed with schizophrenia, bipolar disorder, or a psychotic disorder.
  • A urine drug test at screening shows the presence of recreational drugs other than marijuana.
  • You are currently going through significant alcohol withdrawal symptoms.
  • You are currently pregnant, breastfeeding, or not using a reliable form of birth control (applies to females only).
  • You have a serious medical condition that could make participation unsafe, such as narcolepsy, seizures, or significant heart, liver, kidney, or neurological problems (confirm with trial site).
  • You have taken the sleep medication suvorexant within the 30 days before screening.
  • You are currently taking a prescription medication that does not mix safely with suvorexant (confirm with trial site).
  • You have significant liver problems, based on a blood test result.
  • You are currently experiencing more than moderate thoughts of suicide, as measured by a standard assessment.
  • You are unable to show that you have not had any alcohol for at least 48 hours before the study begins, even after two attempts.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Scott Lane, PhD, The University of Texas Health Science Center, Houston

Phone: 713-486-2535

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Registry
ClinicalTrials.gov
Start date
16 July 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Insomnia Severity Index (ISI) score from baseline to Day 14.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov