Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder (NCT04565028) | Clinical Trial Compass
CompletedNot Applicable
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
United States65 participantsStarted 2022-01-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veteran status
* Ability to speak and write fluent English
* Current PTSD diagnosis
* Use of cannabis on 13+ days in the past month (i.e., use on 3+ days per week)
Exclusion Criteria:
Participants will be excluded if they:
* Have experienced a change in their psychiatric medication regimen during the past month (e.g., a new medication has been prescribed or the dose of an existing medication has been changed), or expect to experience a such a change during the course of the study
* Are receiving non-study CUD treatment
* Meet diagnostic criteria for bipolar disorder or schizophrenia (note that the SCID-5 (First et al., 2015) will be used to diagnoses these and other disorders)
* Become imprisoned
* Become hospitalized for psychiatric reasons
* Report imminent risk for suicide or homicide
* Meet current criteria for a substance use disorder other than cannabis use disorder or tobacco
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This FOCUS trial specifically studied veterans with PTSD who also use cannabis — since it's now completed, has any data been published yet, and what did it find about whether cannabis use helped or hurt day-to-day functioning and quality of life?
2The trial tracked things like work, relationships, and disability using tools like the WHO Disability Assessment Schedule — based on what this study found, does my current level of functional impairment suggest cannabis might be helping or getting in the way of my recovery?
3Since this was a observational study in veterans rather than a randomized controlled trial testing a specific treatment, how much confidence should I place in its findings when thinking about my own PTSD care plan?
4The study measured drugged driving as one of its outcomes, which suggests cannabis-related safety risks were a real concern — is that something we should be actively discussing as part of my treatment, especially if I'm currently using or considering cannabis for PTSD symptoms?
5Given that this trial is completed and focused on veterans, are there other ongoing or newer trials studying cannabis and PTSD that might be a better fit to discuss, or would standard evidence-based PTSD treatments be a stronger starting point for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS)
Timeframe: Baseline and post-treatment (approximately six weeks)
2
Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)
Timeframe: Baseline and post-treatment (approximately six weeks)
3
Change in psychiatric distress
Timeframe: Baseline and post-treatment (approximately six weeks)
4
Change in quality of life, as measured by the WHOQOL-BREF
Timeframe: Baseline and post-treatment (approximately six weeks)
5
Change in quality of life, as measured by the Quality of Life Scale
Timeframe: Baseline and post-treatment (approximately six weeks)
6
Change in number of days of drugged driving as measured by timeline follow-back
Timeframe: Baseline and post-treatment (approximately six weeks)