Phase 1 PTSD Trial, Recruiting NCT06335407 Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance Condition: PTSD
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Phase 1 PTSD Trial, Recruiting

NCT06335407
Recruiting Phase 1

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:

  • People who are between 21 and 65 years old, including both veterans and non-veterans
  • People who can read and write in English and are able to sign a consent form
  • People who are willing to follow all study procedures and attend all required appointments for the full length of the study
  • People whose heart tracing (ECG) shows no significant problems with heart rhythm or electrical signals
  • People who have no major health reasons, based on their medical history and a brief physical check, that would make participation unsafe (as decided by the study doctor)
  • People who have been diagnosed with Alcohol Use Disorder (AUD) — whether mild, moderate, or severe — based on a structured interview used by the study team
  • People who have experienced at least one traumatic event in their lifetime that meets the study's definition of a qualifying trauma, confirmed through a screening interview
  • People who score above 15 on a standard PTSD symptom checklist (PCL-5) before starting the study medication
  • People who have had more than one heavy drinking episode in the past 30 days (defined as more than 4 standard drinks in a day for men, or more than 3 standard drinks in a day for women)
  • Women who could become pregnant must be willing to use an accepted form of birth control for one month before the study and throughout participation — accepted methods include abstinence, the pill, patches, implants, a diaphragm, an IUD, or condoms

Who may not be able to join:

  • People who currently have bipolar disorder or a psychotic disorder, as identified by the study's screening interview
  • People who currently have a substance use disorder involving substances other than alcohol, nicotine, or marijuana
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People whose alcohol dependence is severe enough to require a higher level of medical care, such as a detox program, as determined by the study doctor
  • People who have recently experienced serious alcohol withdrawal symptoms, withdrawal seizures, or a condition called delirium tremens (DTs)
  • People who score above 4 on a standard alcohol withdrawal assessment scale (CIWA-Ar) at the screening visit
  • People with a history of serious medical conditions — including liver disease, heart disease, chronic pain, or other conditions the study doctor considers unsafe for participation
  • People with a significant history of heart-related conditions, including long-term high blood pressure (even if managed with medication), fainting episodes, low blood pressure when standing up, a resting heart rate below 55 beats per minute, low baseline blood pressure, or certain abnormal heart rhythm measurements on an ECG
  • People with significant liver problems, including fluid build-up (ascites) or liver test results that are notably above the normal range
  • People with reduced kidney function, as measured by standard blood tests
  • People currently taking certain medications, including: medications approved for alcohol use disorder (such as naltrexone, disulfiram, topiramate, or acamprosate); medications that cause sedation (such as sleeping pills, barbiturates, certain antihistamines, sedating antidepressants like doxepin, mirtazapine, or trazodone, or migraine medications called triptans); blood pressure medications; certain medications that affect the nervous system (such as clonidine, guanfacine, lofexidine, or prazosin) — note that non-sedating antidepressants used for PTSD are permitted (confirm with trial site)
  • People with a known allergy to the study drug, dexmedetomidine
  • People who have taken part in another drug trial within the 30 days before screening
  • People who have any other finding that, in the study doctor's view, would make it difficult for them to complete the study requirements

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 16 July 2026
Phase 1: approximately ~10% 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: Ismene Petrakis, MD, VA Connecticut Healthcare System

Phone: (203) 932-5711

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 1
Sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Registry
ClinicalTrials.gov
Start date
28 July 2025
Est. completion
30 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.; Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.; Number and Proportion of Adverse Events

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: 16 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