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New treatment option for PTSD
Official title Repurposing Low-Dose Clonidine for PTSD in Veterans
ClinicalTrials.gov ID: NCT04877093
What this study is testing
What is Clonidine Pill?
Clonidine Pill is an investigational medicine, given as an once-daily, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hypothesis: Veterans with PTSD prescribed clonidine will demonstrate improvements in PTSD symptoms, including daytime, nighttime, and sleep-related behaviors.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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
You likely can't join if
- 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...
- 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...
- Urgent hypertension (BP above 160/100) or symptomatic of hypertension (having a hypertensive emergency)
See the full eligibility criteria
- ≥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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wauwatosa, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wauwatosa, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.