Repurposing Low-Dose Clonidine for PTSD in Veterans
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
Hypothesis: Veterans with PTSD prescribed clonidine will demonstrate improvements in PTSD symptoms, including daytime, nighttime, and sleep-related behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Clonidine Pill
DrugThe study will use a flexible-dose adjustment schedule to identify the minimum dose needed to alleviate symptoms while also ensuring acceptable adverse effects. In other words, all subjects will start at the minimum dose (0.1 mg/night). Near the end of every week, each subject will be assessed for symptom alleviation and adverse events by asking the patient two questions from the CAPS-5 (questions B2 and E6. At baseline, each patient will have scored a ≥3 on each of these questions. If one or both scores remain at ≥3 and if any reported adverse events are marked acceptable by both the clinician and subject, then the dosage for the following week will be increased one level according to the titration chart. However, if both scores for these questions are ≤2 and any current adverse events are acceptable, then the dosage will remain the same. Finally, if any adverse events are deemed unacceptable, the clonidine dosage will be reduced to the lowest acceptable daily dosage.
Placebo
Other interventionBlinded placebo capsules will be provided to participants.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Clonidine PhaseExperimental treatment 1 intervention
Group B: Placebo PhasePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 6 weeks into phase
Scored 0-21, where higher scores indicate worse sleep quality.
Time frame
Week 6 of Current Phase2
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) questions B2 and E6 at 6 weeks into phase
Measures PTSD symptoms on sleep, with each question scored 1-4, where higher scores indicate more severe symptoms.
Time frame
Week 6 of Current Phase3
Change from Baseline in PTSD Checklist-Military Version (PCL-5) at 6 weeks into phase
Includes 20 items with a severity score range 0-80. Includes the ability to treat each item rated as 2 = "Moderately" or higher as a symptom endorsed, which allows following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). In general, use of a cutoff score tends to produce more reliable results than the DSM-5 diagnostic rule.
Time frame
Week 6 of Current PhaseSecondary outcomes
1
Change from Baseline in Patient Health Questionnaire (PHQ9) at 6 weeks into phase
Scored 0-27, where higher scores indicate greater depression
Time frame
Week 6 of Current Phase2
Change from Baseline in Sleep Diary at 6 weeks into phase
Qualitative differences in the sleep diary responses
Time frame
Week 6 of Current Phase3
Change from Baseline in quality of life scale (Q-LES-Q-SF) at 6 weeks into phase
Scored 16-80, where higher scores indicate greater quality of life
Time frame
Week 6 of Current PhaseSponsors and contacts
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Source ClinicalTrials.gov