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Clonidine for PTSD and Sleep in Veterans

This study is looking at whether a medication called clonidine can help military veterans with Posttraumatic Stress Disorder (PTSD) improve their symptoms, including issues with sleep. You would receive either clonidine or a placebo (an inactive pill) and start with a low dose of clonidine (0.1 mg/night) which may be adjusted. Researchers will measure changes in your sleep quality and PTSD symptoms after 6 weeks. To join, you must be a US military veteran aged 18 or older with a PTSD diagnosis and specific scores on a PTSD questionnaire (PCL-5). The study aims to enroll 32 participants, but its current recruitment status is unclear.

Study design
This is an interventional study involving 32 participants. It is a blinded study, meaning neither you nor the researchers will know if you are receiving clonidine or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 6 weeks into the phase, which suggests a follow-up period of at least 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04877093

Repurposing Low-Dose Clonidine for PTSD in Veterans

Recruiting
PHASE3Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~32 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Clonidine PillPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phase
Measured over Week 6 of Current Phase
+2 more outcomes measured

Conditions

PTSD
Posttraumatic Stress Disorder
Sleep

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Gregory Burek, MD, MS · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
  • Michael Fendrich, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Kevin Petranu
[email protected]
414-219-2000
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

≥18 years old
US military veteran
Currently has PTSD diagnosis as determined by clinical diagnosing or by the PI
Screening score on PCL5 minimum of 40 (per data from previous studies36-38, a PCL5 score of 40 is roughly equivalent to a CAPS score of 30)
Scores ≥10 on PCL5 items 1-5 (intrusion) or scores ≥10 on PCL5 items 15-20
From PCL5 questionnaire, must score the following minimum in each of the following categories:
1x score of 2 on Questions 1-5
1x score of 2 on Questions 6-7
2x score of 2 on Questions 8-14
2x score of 2 on Questions 15-20
Has score ≥3 on CAPS nightmare items B2 and E6
Speaks and understands English
Willing to come into the clinic as programmed

Exclusion

Pregnant or breastfeeding
At Moderate or High risk of suicide based on "past month" column of the Columbia-Suicide Severity Rating Scale (CSSR-S) screen version - recent.
Has acute or unstable mental illness or any cognitive issues which the PI determines would interfere with engagement in the study (e.g., active schizophrenia, uncontrolled bipolar, history of neurocognitive impairment, history of moderate-severe traumatic brain injury)
Currently receiving exposure therapy
Recently enrolled (\<1 month) in other behavioral health therapies (exclusions made at the PI's discretion depending on therapy type and length since admission)
Urgent hypertension (BP above 160/100) or symptomatic of hypertension (having a hypertensive emergency)
Blood pressure under 100/60 or symptoms of low blood pressure (light headedness, dizziness, heart palpitations, or other symptoms as determined by clinician).
Any contraindications to taking clonidine such as:
Known hypersensitivity to clonidine
History of 2nd or 3rd degree atrioventricular block
History of sinus bradycardia
History of pheochromocytoma
History of Raynaud's phenomenon
Stage 5 Kidney disease
Recent myocardial infarction (\<6 months)
History of cerebrovascular disease or recent stoke (\<6 months)
Have used any of the following drugs in the past 30 days, unprescribed or not used as prescribed:
Heroin
Other opiates/analgesics
Barbiturates
Other sedatives/, hypnotics, or tranquilizers
Cocaine
Amphetamines
Cannabis
Hallucinogens
Inhalants
Currently have any of the following diagnoses:
Opioid use disorder
Cocaine use disorder
Alcohol use disorder
Cannabis use disorder
Sleep apnea diagnosis with verbal indication of non-adherence to treatment
Were prescribed clonidine within the last 6 months
Any α2 agonist
Catapres/Kapvay (clonidine)
Aldomet (Methyldopa)
Zanaflex (Tizanidine)
Intuniv (Guanfacine)
Lucemyra (Lofexidine)
Any α1-adrenergic antagonist
Prazosin
Terazosin
Doxazosin
Silodosin
Alfuzosin
Tamsulosin
Any opiate (e.g., buprenorphine, hydrocodone, oxycodone)
Any antipsychotic medication
Haldol (haloperidol)
Loxitane (loxapine)
Mellaril (thioridazine)
Moban (molindone)
Navane (thiothixene)
Prolixin (fluphenazine)
Serentil (mesoridazine)
Stelazine (trifluoperazine)
Trilafon (perphenazine)
Thorazine (chlorpromazine)
Abilify (aripiprazole)
Clozaril (clozapine)
Geodon (ziprasidone)
Risperdal (risperidone)
Seroquel (quetiapine)
Zyprexa (olanzapine)
Benzodiazepines
Cyproheptadine
Based on PI or study team assessment is cognitively unable to engage in the study
Has a legal guardian

What this trial measures

  • Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phaseWeek 6 of Current Phase

    Scored 0-21, where higher scores indicate worse sleep quality.

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) questions B2 and E6 at 6 weeks into phaseWeek 6 of Current Phase

    Measures PTSD symptoms on sleep, with each question scored 1-4, where higher scores indicate more severe symptoms.

  • Change from Baseline in PTSD Checklist-Military Version (PCL-5) at 6 weeks into phaseWeek 6 of Current Phase

    Includes 20 items with a severity score range 0-80. Includes the ability to treat each item rated as 2 = "Moderately" or higher as a symptom endorsed, which allows following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). In general, use of a cutoff score tends to produce more reliable results than the DSM-5 diagnostic rule.