Active — Not RecruitingNot 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 range18 Years

SexALL

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

What they're measuring

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)

Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in psychiatric distress

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in quality of life, as measured by the WHOQOL-BREF

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in quality of life, as measured by the Quality of Life Scale

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in number of days of drugged driving as measured by timeline follow-back

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in cannabis use

Timeframe: Baseline and post-treatment (approximately six weeks)

Trial details

NCT IDNCT04565028

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-06-05

View on ClinicalTrials.gov More PTSD trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in psychiatric distress

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in quality of life, as measured by the WHOQOL-BREF

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in quality of life, as measured by the Quality of Life Scale

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in number of days of drugged driving as measured by timeline follow-back

Timeframe: Baseline and post-treatment (approximately six weeks)

Change in cannabis use

Timeframe: Baseline and post-treatment (approximately six weeks)