RecruitingPhase 3NCT04877093

Repurposing Low-Dose Clonidine for PTSD in Veterans


Sponsor

Wake Forest University Health Sciences

Enrollment

32 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Hypothesis: Veterans with PTSD prescribed clonidine will demonstrate improvements in PTSD symptoms, including daytime, nighttime, and sleep-related behaviors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether low-dose clonidine — a medication originally used for high blood pressure — can reduce PTSD symptoms, especially nightmares and intrusive memories, in military veterans. Clonidine reduces norepinephrine activity in the brain, which may calm the overactive stress response seen in PTSD. **You may be eligible if...** - You are a US military veteran aged 18 or older with a confirmed PTSD diagnosis - You score at least 40 on the PCL-5 PTSD symptom checklist - You have significant intrusion symptoms (flashbacks, nightmares) and hyperarousal symptoms - You speak and understand English - You are willing to attend clinic visits as scheduled **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are at moderate or high risk of suicide - You have severe unstable mental illness (active schizophrenia, uncontrolled bipolar, significant traumatic brain injury) - You are currently in exposure-based therapy or recently started another behavioral health therapy - Your blood pressure is urgently high (above 160/100) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClonidine Pill

The study will use a flexible-dose adjustment schedule to identify the minimum dose needed to alleviate symptoms while also ensuring acceptable adverse effects. In other words, all subjects will start at the minimum dose (0.1 mg/night). Near the end of every week, each subject will be assessed for symptom alleviation and adverse events by asking the patient two questions from the CAPS-5 (questions B2 and E6. At baseline, each patient will have scored a ≥3 on each of these questions. If one or both scores remain at ≥3 and if any reported adverse events are marked acceptable by both the clinician and subject, then the dosage for the following week will be increased one level according to the titration chart. However, if both scores for these questions are ≤2 and any current adverse events are acceptable, then the dosage will remain the same. Finally, if any adverse events are deemed unacceptable, the clonidine dosage will be reduced to the lowest acceptable daily dosage.

OTHERPlacebo

Blinded placebo capsules will be provided to participants.


Locations(1)

Aurora Psychiatric Hospital

Wauwatosa, Wisconsin, United States

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NCT04877093


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