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RECRUITING
NCT04877093
PHASE3

Repurposing Low-Dose Clonidine for PTSD in Veterans

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-06-01

Completion Date

2027-03-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Clonidine 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.

OTHER

Placebo

Blinded placebo capsules will be provided to participants.

Locations (1)

Aurora Psychiatric Hospital

Wauwatosa, Wisconsin, United States