RECRUITING

Repurposing Low-Dose Clonidine for PTSD in Veterans

Conditions

PTSD Posttraumatic Stress Disorder Sleep veterans military adrenergic receptor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Repurposing Low-Dose Clonidine for PTSD in Veterans

Quick Facts

Study Start:2023-06-01

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04877093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, 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

Inclusion Criteria

Exclusion 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, 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

Contacts and Locations

Study Contact

Kevin Petranu

CONTACT

414-219-2000

kevin.petranu@aah.org

Principal Investigator

Gregory Burek, MD, MS

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Michael Fendrich, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Aurora Psychiatric Hospital

Wauwatosa, Wisconsin, 53213

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

PTSD
veterans
military
sleep
adrenergic receptor

Additional Relevant MeSH Terms

PTSD
Posttraumatic Stress Disorder
Sleep