Repurposing Low-Dose Clonidine for PTSD in Veterans

Part of paid clinical trials in Wauwatosa, Wisconsin.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04877093
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clonidine Pill — DRUG
    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.
  • Placebo — OTHER
    Blinded placebo capsules will be provided to participants.

Study Details

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

Key Dates

Start date
Jun 1, 2023
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Clonidine Phase
    Participants will receive clonidine titrations across 6 weeks. Note that this is a crossover design, so patients will move across phases.
  • Placebo Comparator: Placebo Phase
    Participants will receive placebo titrations across 6 weeks. Note that this is a crossover design, so patients will move across phases.

Primary Outcome Measure

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phase [ Time Frame: Week 6 of Current Phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Aurora Psychiatric HospitalWauwatosaWisconsin53213
Michael Fendrich, PhD
[email protected]
Gregory A Burek, MD, MS (PRINCIPAL_INVESTIGATOR)
Michael Fendrich, PhD (SUB_INVESTIGATOR)

Find similar trials in Wauwatosa, WI

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Aurora Psychiatric Hospital· Wauwatosa, WI

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