Clinical trial NCT04565028: Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
Official title: Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Cannabis-Related Disorder
Keywords: PTSD
Cannabis-Related Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: 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; however, 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 prospectively study the impact of reduced cannabis use on psychosocial functioning among Veterans with PTSD. To do so, the investigators will first use ecological momentary assessment (EMA) methods to evaluate the relationship between cannabis use and daily functioning among Veterans with PTSD. Next, the investigators will use mobile contingency management (CM) and EMA to assess the impact of reduced cannabis use on daily functioning among Veterans with PTSD who are 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. As a result, this innovative and timely project has the potential to significantly advance VHA healthcare and will directly inform the ongoing national debate concerning the impact of cannabis use on the long-term functional recovery of Veterans with PTSD.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)
timeFrame: Baseline and post-treatment (approximately six weeks)
measure: Change in psychiatric distress
timeFrame: Baseline and post-treatment (approximately six weeks)
measure: Change in quality of life, as measured by the WHOQOL-BREF
timeFrame: Baseline and post-treatment (approximately six weeks)
measure: Change in quality of life, as measured by the Quality of Life Scale
timeFrame: Baseline and post-treatment (approximately six weeks)
measure: Change in number of days of drugged driving as measured by timeline follow-back
timeFrame: Baseline and post-treatment (approximately six weeks)
measure: Change in cannabis use
timeFrame: Baseline and post-treatment (approximately six weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Jean C Beckham, PhD
role: PRINCIPAL_INVESTIGATOR
References: