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NCT04565028 · ClinicalTrials.gov registry record · NA
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
A NA study of PTSD and Cannabis-Related Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04565028: Recruiting NA study of PTSD and Cannabis-Related Disorder, sponsored by VA Office of Research and Development.
NCT04565028 is a NA study of PTSD and Cannabis-Related Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 40 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565028, a NA study of PTSD and Cannabis-Related Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to study the impact of reduced cannabis use on functioning among Veterans with PTSD. The investigators will evaluate the relationship between cannabis use and daily functioning among cannabis users and heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD.
Primary Outcome
Functional impairment will be measured by the simple score on the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS). This measure has a scoring range of 0 to 144, with lower scores indicating lower functional impairment.
Conditions Studied
Interventions
- BEHAVIORAL Contingency Management (CM)
Study Locations (1)
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-26 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What NCT04565028 shows while recruiting
NCT04565028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which Contingency Management (CM) is the first listed.
NCT04565028 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04565028 about?
NCT04565028 is a clinical study titled "Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder". Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be ...
What is the current status of trial NCT04565028?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2022-01-26. Estimated completion is 2026-03-31.
What conditions does trial NCT04565028 study?
This clinical trial studies the following conditions: PTSD, Cannabis-Related Disorder.
What interventions are being tested in trial NCT04565028?
The interventions under investigation include: Contingency Management (CM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04565028?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04565028 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04565028's enrollment target sits among peer trials
40 106th of 154 higher than 41 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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