PTSDFOCUSNCT04565028
Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
A study testing Contingency Management (CM) in people with PTSD and Cannabis-Related Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Cannabis-Related Disorder
- What is being tested?
- Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
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.
Read the 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.
- Conditions
- PTSD, Cannabis-Related Disorder
- Being tested
- Contingency Management (CM)
- Keywords
- PTSD, Cannabis-Related Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management (CM)Behavioural
Also called Mobile Contingency Management (mCM)
Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Contingency Management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-treatment (approximately six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start26 Jan 2022
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jean C Beckham, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565028
- Sponsor's protocol ID
- D3276-R
- Acronym
- FOCUS
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to attend individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Cannabis Use (FOCUS) in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04565028
- Acronym / sponsor ID
- FOCUS / D3276-R
- Conditions
- PTSD, Cannabis-Related Disorder
- Keywords
- PTSD, Cannabis-Related Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency Management (CM) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency Management (CM)Also: Mobile Contingency Management (mCM)Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use. | Behavioural | Contingency Management (CM) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. The investigators do not plan to attend individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean C Beckham, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management (CM) in people with PTSD and Cannabis-Related Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.