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NCT04721353 · ClinicalTrials.gov registry record · Phase 4
Reducing Cannabis Overuse With Prazosin
A Phase 4 study of Posttraumatic Stress Disorder and Cannabis Use Disorder, sponsored by VA Puget Sound Health Care System.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04721353 is a Phase 4 study of Posttraumatic Stress Disorder and Cannabis Use Disorder that has completed, run by VA Puget Sound Health Care System. The registered enrollment target is 11 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04721353, a Phase 4 study of Posttraumatic Stress Disorder and Cannabis Use Disorder, has completed, sponsored by VA Puget Sound Health Care System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts have been reported as troublesome symptoms targeted by cannabis users. Risks from cannabis use by individuals with PTSD have been reported. Chronic use of cannabis can lead to tolerance, requiring increased use for symptom relief, and withdrawal symptoms upon stopping. CUD is more frequent and severe in those with PTSD than those without. Many symptoms of cannabis withdrawal overlap with troubling symptoms of PTSD and thus may be interpreted as a relapse of PTSD symptoms. Those attempting to reduce or stop cannabis use may experience cannabis withdrawal symptoms including insomnia and distressing dreams, anxiety, irritability, and/or excessive sweating that they may misattribute to re-emerging or untreated PTSD symptoms. Excessive brain adrenaline activity is arguably the best-described neurobiological contribution to the pathophysiology of PTSD. Prazosin, a drug that blocks the negative effects of brain adrenaline, has demonstrated effectiveness in robustly reducing PTSD-related nightmares and sleep disturbance in active duty Servicemembers and recently discharged combat Veterans in most, but not all, clinical trials, as well as in civilians with non-combat trauma. Clinically, the investigators have observed that several patients with PTSD using cannabis to treat insomnia and/or trauma-related nightmares and wanting to reduce their cannabis use were able to achieve reduction or cessation of cannabis use once they were treated with an effective dose of prazosin. Therefore, we have wondered if prazosin may provide sufficient treatment of PTSD symptoms otherwise targeted by cannabis, supporting those individuals' efforts to reduce cannabis use. This open-label pilot study a
Conditions Studied
Interventions
- DRUG Prazosin Hydrochloride
Study Locations (1)
Washington
- VA Puget Sound Health Care System - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721353
The ClinicalTrials.gov registry entry for NCT04721353 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (90% lower). The listed sponsor is VA Puget Sound Health Care System, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Prazosin Hydrochloride is the first listed.
NCT04721353 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT04721353 about?
NCT04721353 is a clinical study titled "Reducing Cannabis Overuse With Prazosin". Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts ha...
What is the current status of trial NCT04721353?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2020-11-09. Estimated completion is 2025-06-01.
What conditions does trial NCT04721353 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder, Cannabis Use Disorder, Cannabis Dependence.
What interventions are being tested in trial NCT04721353?
The interventions under investigation include: Prazosin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04721353?
This trial is sponsored by VA Puget Sound Health Care System, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04721353 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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