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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 Aurora Health Care
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 of current phase
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 of current phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 of current phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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?

Aurora Health CareLead Sponsor
41 Previous Clinical Trials
15,750 Total Patients Enrolled
Mindy R Waite, PhD, MSPrincipal InvestigatorAdvocate Aurora Health
Gregory Burek, MD, MSPrincipal InvestigatorAdvocate Health Care

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04877093 — Phase 3
Post-Traumatic Stress Disorder Research Study Groups: Clonidine Phase, Placebo Phase
Post-Traumatic Stress Disorder Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT04877093 — Phase 3
Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04877093 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the researchers hoping to achieve with this clinical trial?

"This study will assess the primary outcome of change in PTSD symptoms as measured by the PCL-5 scale at 6 weeks. Secondary outcomes include qualitative data on participants' verbal feedback and changes in heart rate and clinical global impressions from baseline at 6 weeks."

Answered by AI

Are there any other investigations that have included Clonidine Pill in their research?

"As of now, there are 23 clinical trials ongoing for Clonidine Pill. Of these, 7 have reached Phase 3. Although a number of the studies are based in Boston, Massachusetts, 75 different locations across the globe are running tests for this pill."

Answered by AI

What are the harmful effects of Clonidine Pill?

"Clonidine Pill has been studied in multiple Phase 3 trials, which provides some efficacy data and supports the safety of the medication."

Answered by AI

What is the primary condition that Clonidine Pill treats?

"Clonidine pill is most frequently used to manage diabetic diarrhea, but it can also help patients dealing with menopause, attention deficit hyperactivity disorder (adhd), and pheochromocytomas."

Answered by AI

Are new participants being enrolled in this experiment at present?

"According to the most recent information available on clinicaltrials.gov, this trial is not recruiting patients at this time. The study was posted on February 1st 2023 and last updated on November 1st 2022. 595 other studies are currently enrolling patients."

Answered by AI

How many test subjects are involved in this clinical trial?

"Currently, this trial is not looking for patients. The study was first posted on February 1st 2023 and the most recent edit was on November 1st 2022. If you are interested in other studies, 572 trials for post-traumatic stress disorder (ptsd) and 23 trials for Clonidine Pill are presently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Aurora Psychiatric Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Sleep disorder and nightmares bad.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Aurora Psychiatric Hospital: < 48 hours
~18 spots leftby Mar 2025