Phase 3 PTSD Trial, Recruiting NCT04877093 Sponsor: Wake Forest University Health Sciences Condition: PTSD
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Phase 3 PTSD Trial, Recruiting

NCT04877093
Recruiting Phase 3

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 18 years old or older
  • You are a U.S. military veteran
  • You have been diagnosed with PTSD, either by a doctor or confirmed by the study team
  • Your score on a PTSD symptom checklist (called the PCL-5) is at least 40
  • Your PCL-5 scores show a high enough level of certain PTSD symptoms, including intrusive thoughts or emotional/physical reactions (confirm with trial site for exact scoring details)
  • Your responses on the PCL-5 questionnaire meet specific minimum scores across several symptom categories (confirm with trial site for exact details)
  • You experience nightmares at a level of at least 3 on a specific clinical rating scale
  • You speak and understand English
  • You are willing and able to attend clinic visits as scheduled

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You are considered at moderate or high risk for suicide based on a recent standardized safety screening
  • You have an unstable or active serious mental health condition, or cognitive difficulties that the study doctor believes would get in the way of participating (for example, active schizophrenia, uncontrolled bipolar disorder, a history of significant memory or thinking problems, or a moderate to severe brain injury)
  • You are currently receiving a type of therapy called exposure therapy
  • You recently started (within the last month) another mental health or behavioral therapy program (the study doctor will decide on a case-by-case basis)
  • Your blood pressure is too high — above 160/100 — or you are experiencing a blood pressure emergency
  • Your blood pressure is too low — below 100/60 — or you have symptoms of low blood pressure such as dizziness, lightheadedness, or heart palpitations
  • You have a known allergy or sensitivity to a medication called clonidine
  • You have a history of certain heart conditions, including specific types of heart rhythm problems (confirm with trial site for full details)
  • You have a history of a tumor called pheochromocytoma
  • You have a history of a circulation condition called Raynaud's phenomenon
  • You have stage 5 kidney disease
  • You had a heart attack within the last 6 months
  • You have a history of stroke or blood vessel disease in the brain, or had a stroke within the last 6 months
  • You have used any of the following substances without a prescription, or not as prescribed, in the past 30 days: heroin, opioid painkillers, barbiturates, sedatives or tranquilizers, cocaine, amphetamines, cannabis, hallucinogens, or inhalants
  • You currently have a diagnosed substance use disorder involving opioids, cocaine, alcohol, or cannabis
  • You have been diagnosed with sleep apnea and have said you are not following your prescribed treatment for it
  • You have been prescribed certain medications within the last 6 months, including: clonidine or similar blood pressure medications (alpha-2 agonists), certain other blood pressure medications (alpha-1 blockers such as prazosin or tamsulosin), opioid medications, antipsychotic medications, benzodiazepines, or a medication called cyproheptadine (confirm with trial site for the full list)
  • The study doctor or team determines that you are not able to fully participate due to cognitive difficulties
  • You have a legal guardian

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 28 July 2026
Phase 3: approximately ~65% 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: Gregory Burek, MD, MS, Wake Forest University Health Sciences

Phone: 414-219-2000

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 3
Registry
ClinicalTrials.gov
Start date
1 June 2023
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phase; Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) questions B2 and E6 at 6 weeks into phase; Change from Baseline in PTSD Checklist-Military Version (PCL-5) at 6 weeks into phase

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: 28 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