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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04565028
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
PTSD Cannabis-Related Disorder Behavioral: Contingency Management (CM) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Contingency Management (CM)
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.
 Behavioral: Contingency Management (CM)
Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.
Other Name: Mobile Contingency Management (mCM)


Outcome Measures
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Primary Outcome Measures :
  1. Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS) [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.

  2. Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF) [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.

  3. Change in psychiatric distress [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.

  4. Change in quality of life, as measured by the WHOQOL-BREF [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.

  5. Change in quality of life, as measured by the Quality of Life Scale [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.

  6. Change in number of days of drugged driving as measured by timeline follow-back [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    Number of days of drugged driving in the past month will be self-reported by participants using a Timeline Follow-Back Interview.

  7. Change in cannabis use [ Time Frame: Baseline and post-treatment (approximately six weeks) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565028


Contacts
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Contact: Angela C Kirby, MS (919) 286-0411 ext 7456 angela.kirby@va.gov
Contact: Jean C Beckham, PhD (919) 286-0411 ext 7973 jean.beckham@va.gov

Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Contact: Angela C Kirby, MS    919-286-0411 ext 7456    angela.kirby@va.gov   
Contact: Jean C Beckham, PhD    (919) 286-0411 ext 7973    jean.beckham@va.gov   
Principal Investigator: Jean C Beckham, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jean C Beckham, PhD Durham VA Medical Center, Durham, NC
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04565028    
Other Study ID Numbers: D3276-R
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to attend individual participant data.

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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
Keywords provided by VA Office of Research and Development:
PTSD
Cannabis-Related Disorder
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
 Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders