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

NCT ID: NCT04565028

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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PTSD Cannabis-Related Disorder

Keywords

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PTSD Cannabis-Related Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Contingency Management (CM)

Intervention Type BEHAVIORAL

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

Interventions

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Contingency Management (CM)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Mobile Contingency Management (mCM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean C Beckham, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

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Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela C Kirby, MS

Role: CONTACT

Phone: (919) 286-0411

Email: [email protected]

Jean C Beckham, PhD

Role: CONTACT

Phone: (919) 286-0411

Email: [email protected]

Facility Contacts

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Angela C Kirby, MS

Role: primary

Jean C Beckham, PhD

Role: backup

Other Identifiers

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D3276-R

Identifier Type: -

Identifier Source: org_study_id