Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder (FOCUS)
Primary Purpose
PTSD, Cannabis-Related Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management (CM)
Sponsored by
About this trial
This is an interventional other trial for PTSD focused on measuring PTSD, Cannabis-Related Disorder
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
Sites / Locations
- Durham VA Medical Center, Durham, NCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contingency Management (CM)
Arm Description
Mobile contingency management (CM) will be used to promote reductions in cannabis use among Veterans with PTSD who are heavy cannabis users. CM is an intensive behavioral therapy in which participants are paid to reduce substance use.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04565028
First Posted
September 18, 2020
Last Updated
January 5, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04565028
Brief Title
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
Acronym
FOCUS
Official Title
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Cannabis-Related Disorder
Keywords
PTSD, Cannabis-Related Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contingency Management (CM)
Arm Type
Experimental
Arm Description
Mobile contingency management (CM) will be used to promote reductions in cannabis use among Veterans with PTSD who are heavy cannabis users. CM is an intensive behavioral therapy in which participants are paid to reduce substance use.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management (CM)
Other Intervention Name(s)
Mobile Contingency Management (mCM)
Intervention Description
Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.
Primary Outcome Measure Information:
Title
Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS)
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in psychiatric distress
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in quality of life, as measured by the WHOQOL-BREF
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in quality of life, as measured by the Quality of Life Scale
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in number of days of drugged driving as measured by timeline follow-back
Description
Number of days of drugged driving in the past month will be self-reported by participants using a Timeline Follow-Back Interview.
Time Frame
Baseline and post-treatment (approximately six weeks)
Title
Change in cannabis use
Description
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.
Time Frame
Baseline and post-treatment (approximately six weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jean C Beckham, PhD
Phone
(919) 286-0411
Ext
7973
Email
jean.beckham@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela C Kirby, MS
Phone
919-286-0411
Ext
7456
Email
angela.kirby@va.gov
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, PhD
Phone
(919) 286-0411
Ext
7973
Email
jean.beckham@va.gov
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan to attend individual participant data.
Learn more about this trial
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
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