RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2022-01-26
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04565028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran status
  2. * Ability to speak and write fluent English
  3. * Current PTSD diagnosis
  4. * Use of cannabis on 13+ days in the past month (i.e., use on 3+ days per week)
  1. * 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
  2. * Are receiving non-study CUD treatment
  3. * 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)
  4. * Become imprisoned
  5. * Become hospitalized for psychiatric reasons
  6. * Report imminent risk for suicide or homicide
  7. * Meet current criteria for a substance use disorder other than cannabis use disorder or tobacco

Contacts and Locations

Study Contact

Angela C Kirby, MS
CONTACT
(919) 286-0411
angela.kirby@va.gov
Jean C Beckham, PhD
CONTACT
(919) 286-0411
jean.beckham@va.gov

Principal Investigator

Jean C Beckham, PhD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jean C Beckham, PhD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-26
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2022-01-26
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Cannabis-Related Disorder

Additional Relevant MeSH Terms

  • PTSD
  • Cannabis-Related Disorder