Repurposing Low-Dose Clonidine for PTSD in Veterans

Inclusion 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 PCL5score 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 followingcategories:

• 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 Criteria:

• Pregnant or breastfeeding

• At Moderate or High risk of suicide based on "past month" column of theColumbia-Suicide Severity Rating Scale (CSSR-S) screen version - recent.

• Has acute or unstable mental illness or any cognitive issues which the PI determineswould interfere with engagement in the study (e.g., active schizophrenia,uncontrolled bipolar, history of neurocognitive impairment, history ofmoderate-severe traumatic brain injury)

• Currently receiving exposure therapy

• Recently enrolled (<1 month) in other behavioral health therapies (exclusions madeat the PI's discretion depending on therapy type and length since admission)

• Urgent hypertension (BP above 160/100) or symptomatic of hypertension (having ahypertensive 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 usedas 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