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Alpha-2 Adrenergic Agonist
Low-Dose Clonidine for PTSD
Phase 3
Recruiting
Led By Mindy R Waite, PhD, MS
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years old
Currently has PTSD diagnosis as determined by clinical diagnosing
Must not have
Currently receiving exposure therapy
Urgent hypertension (BP above 160/100) or symptomatic of hypertension (having a hypertensive emergency)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 of current phase
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether the drug clonidine can help improve symptoms of PTSD in veterans. It will look at daytime, nighttime, and sleep-related behaviors.
Who is the study for?
This trial is for US military veterans over 18 with PTSD, who have specific scores on the PCL5 and CAPS assessments indicating intrusion or nightmares. Participants must speak English and be willing to visit the clinic as required. Excluded are those with certain heart conditions, severe hypertension, kidney disease, recent heart attack or stroke, drug use disorders, other mental health issues that could interfere with participation, or those taking conflicting medications.
What is being tested?
The study tests if low-dose clonidine can improve PTSD symptoms in veterans compared to a placebo. The hypothesis suggests benefits in daytime behavior and sleep-related issues. Participants will receive either clonidine pills or a placebo without knowing which one they're getting.
What are the potential side effects?
Clonidine may cause side effects like dizziness, dry mouth, fatigue, headache and potentially low blood pressure. It's important for participants to report any discomfort they experience during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with PTSD by a healthcare professional.
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I am 18 years old or older.
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I have been diagnosed with PTSD by a healthcare professional.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing exposure therapy.
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My blood pressure is above 160/100 or I am experiencing a hypertensive emergency.
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My blood pressure is below 100/60 or I experience symptoms like dizziness.
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I have a history of slow heartbeats.
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I have a history of pheochromocytoma.
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I have a history of Raynaud's phenomenon.
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My kidney disease is in stage 5.
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I have not used any unprescribed drugs or misused prescribed ones in the last 30 days.
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I am taking pain medication other than opiates.
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I am not taking any barbiturate medications.
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I am not taking sedatives, sleeping pills, or tranquilizers.
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I have sleep apnea and do not follow my treatment plan.
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I have been prescribed clonidine in the last 6 months.
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I am taking an α2 agonist medication.
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I am taking medication for high blood pressure or prostate issues.
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I am currently taking or have taken opiates like buprenorphine, hydrocodone, or oxycodone.
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I am taking antipsychotic medication.
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I am currently taking benzodiazepines.
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I am taking Cyproheptadine.
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I have a legal guardian.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6 of current phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 of current phase
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) questions B2 and E6 at 6 weeks into phase
Change from Baseline in PTSD Checklist-Military Version (PCL-5) at 6 weeks into phase
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phase
Secondary study objectives
Change from Baseline in Patient Health Questionnaire (PHQ9) at 6 weeks into phase
Change from Baseline in Sleep Diary at 6 weeks into phase
Change from Baseline in quality of life scale (Q-LES-Q-SF) at 6 weeks into phase
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Clonidine PhaseExperimental Treatment1 Intervention
Participants will receive clonidine titrations across 6 weeks. Note that this is a crossover design, so patients will move across phases.
Group II: Placebo PhasePlacebo Group1 Intervention
Participants will receive placebo titrations across 6 weeks. Note that this is a crossover design, so patients will move across phases.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,273 Total Patients Enrolled
Aurora Health CareLead Sponsor
45 Previous Clinical Trials
16,386 Total Patients Enrolled
Mindy R Waite, PhD, MSPrincipal InvestigatorAdvocate Aurora Health
Gregory Burek, MD, MSPrincipal InvestigatorWake Forest University Health Sciences
Michael Fendrich, PhDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
1,279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a former member of the US military.I am taking Catapres or Kapvay (clonidine).I am taking Aldomet (Methyldopa).You have experienced traumatic events and have symptoms such as flashbacks or nightmares (PCL5 items 1-5) or avoidance of thoughts or feelings related to the event (PCL5 items 15-20) with a score of 10 or higher.You have used or are currently using cannabis.I have been prescribed clonidine in the last 6 months.I am taking Seroquel (quetiapine).You have a score of 3 or more on the CAPS nightmare items B2 and E6.My kidney disease is in stage 5.I am not taking any barbiturate medications.You are not allowed to use inhalants during the study.I am taking an α2 agonist medication.I have a legal guardian.I am not taking Moban (molindone).I am currently taking Navane (thiothixene).I am taking Prolixin for my condition.I am taking Thorazine.I am currently taking Abilify.I am taking Clozaril (clozapine).I am currently taking benzodiazepines.I am taking Cyproheptadine.You have high scores on questions related to intrusive thoughts or disturbing memories.I have a current diagnosis.I can safely take clonidine without any known contraindications.You have an addiction to opioid drugs.You can speak and understand English.You have a history of a specific heart condition called 2nd or 3rd degree atrioventricular block.I am not taking Serentil (mesoridazine).I have a history of Raynaud's phenomenon.You are a former member of the US military.My blood pressure is above 160/100 or I am experiencing a hypertensive emergency.You are allergic to clonidine.I have a history of slow heartbeats.I have a history of pheochromocytoma.I am taking Tamsulosin.You have a screening score of 30 or higher on the CAPS.I am taking medication for high blood pressure or prostate issues.I am currently taking Alfuzosin.You are currently using heroin.You have answered questions 15-20 with a score of 2 or higher, twice.You are able to speak and understand English.I am taking Haldol (haloperidol).I am taking Loxitane (loxapine).I am currently taking or have taken opiates like buprenorphine, hydrocodone, or oxycodone.I am taking Lucemyra (Lofexidine).I am not taking Mellaril for my condition.I am currently taking Geodon (ziprasidone).I am taking Risperdal (risperidone).I am considered unable to understand or participate in the study due to cognitive reasons.I am 18 years old or older.I am currently undergoing exposure therapy.I haven't started any new mental health therapies in the last month.My blood pressure is below 100/60 or I experience symptoms like dizziness.I have not had a heart attack in the last 6 months.I am taking pain medication other than opiates.I have sleep apnea and do not follow my treatment plan.You have a problem with using marijuana.I am taking Silodosin.I have been diagnosed with PTSD by a healthcare professional.I am currently taking Prazosin.I am taking Trilafon (perphenazine).I am 18 years old or older.I have been diagnosed with PTSD by a healthcare professional.I am currently taking Terazosin.I am currently taking Doxazosin.I have not used any unprescribed drugs or misused prescribed ones in the last 30 days.I am currently taking Zanaflex (Tizanidine).I am taking Zyprexa (olanzapine).You have a problem with drinking too much alcohol.I am taking Intuniv (Guanfacine).I am taking Stelazine for my condition.I have had a stroke or cerebrovascular disease in the last 6 months.I am taking antipsychotic medication.I am not taking sedatives, sleeping pills, or tranquilizers.
Research Study Groups:
This trial has the following groups:- Group 1: Clonidine Phase
- Group 2: Placebo Phase
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.