Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder

PTSD Clinical Trial

— FOCUS  

Official title:

Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565028
• Other study ID #: D3276-R
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Angela C Kirby, MS
• Phone: (919) 286-0411
• Email: angela.kirby[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabis-Related Disorder
• Marijuana Abuse
• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Contingency Management (CM)
Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS)	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.	Baseline and post-treatment (approximately six weeks)
Primary	Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)	Functional impairment will be measured by the Inventory of Psychosocial Functioning (IPF). This measure has a scoring range of 0 to 480, with lower scores indicating higher functional impairment.	Baseline and post-treatment (approximately six weeks)
Primary	Change in psychiatric distress	Psychiatric distress will be measured by the 90-item Symptom Checklist (SCL-90). This measure has a scoring range of 0 to 360, with lower scores indicating lower distress related to mental health.	Baseline and post-treatment (approximately six weeks)
Primary	Change in quality of life, as measured by the WHOQOL-BREF	Quality of life will be measured with the World Health Organization Quality of Life Brief (WHOQOL-BREF). The measure has a scoring range of 0 to 100, with higher scores denoting a higher quality of life.	Baseline and post-treatment (approximately six weeks)
Primary	Change in quality of life, as measured by the Quality of Life Scale	Quality of life will be measured with the 16-item Quality of Life Scale. The measure has a scoring range of 6 to 112, with higher scores denoting a higher quality of life.	Baseline and post-treatment (approximately six weeks)
Primary	Change in number of days of drugged driving as measured by timeline follow-back	Number of days of drugged driving in the past month will be self-reported by participants using a Timeline Follow-Back Interview.	Baseline and post-treatment (approximately six weeks)
Primary	Change in cannabis use	Cannabis use, as measured in milligrams, will be measured by taking the product of number of days used and amount used per day in the previous week.	Baseline and post-treatment (approximately six weeks)