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

NCT04565028 | Active Not Recruiting

• 1 other identifier: D3276-R
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Cannabis-Related Disorder

Keywords

PTSD; Cannabis-Related Disorder

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Contingency Management (CM)

EXPERIMENTAL

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)

Interventions

Contingency Management (CM) BEHAVIORAL

Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.

Also known as: Mobile Contingency Management (mCM)

Contingency Management (CM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Marijuana Abuse

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jean C Beckham, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 25, 2020
• Study Start: January 26, 2022
• Primary Completion: June 5, 2026
• Study Completion: June 5, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)