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Contingency Management for PTSD (FOCUS Trial)
N/A
Recruiting
Led By Jean C Beckham, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current PTSD diagnosis
Be older than 18 years old
Must not have
Become hospitalized for psychiatric reasons
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-treatment (approximately six weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of reduced cannabis use on functioning for veterans with PTSD. The hypothesis is that less cannabis use will lead to better functioning.
Who is the study for?
This trial is for U.S. Veterans with PTSD who frequently use cannabis (13+ days in the past month) and can communicate in English. It's not open to those who've changed psychiatric meds recently, are getting non-study treatment for Cannabis Use Disorder, have been hospitalized or imprisoned, or have bipolar disorder, schizophrenia, or a substance use disorder other than cannabis.
What is being tested?
The FOCUS trial investigates whether reducing cannabis use improves daily functioning in Veterans with PTSD. The study uses Contingency Management (CM), which rewards individuals for meeting goals like reduced substance use.
What are the potential side effects?
Since this study focuses on reducing cannabis use rather than administering drugs, it does not directly involve side effects from interventions. However, participants may experience withdrawal symptoms from lessened cannabis usage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been hospitalized for mental health reasons.
Select...
I have been diagnosed with bipolar disorder or schizophrenia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post-treatment (approximately six weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-treatment (approximately six weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cannabis use
Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)
Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS)
+4 moreSide effects data
From 2021 Phase 2 trial • 118 Patients • NCT028967124%
Nausea
4%
Headache
2%
Suicidal Ideation
2%
Not Sleeping Well
2%
Vomiting
2%
Shortness of Breath
2%
Domestic Violence/Abuse
2%
Stomach Flu
2%
Tremor
2%
Stomach Pain
2%
Muscle Aches
2%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only
Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only
Phase 2: ACT Plus CM Only
Phase 2: ACT Plus CM, With Placebo
Phase 2: ACT Plus CM, With Modafinil
Phase 2: DC Plus CM Only
Phase 2: DC Plus CM, With Placebo
Phase 2: DC Plus CM, With Modafinil
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Contingency Management (CM)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency Management (CM)
2016
Completed Phase 2
~480
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,427,248 Total Patients Enrolled
Jean C Beckham, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
283 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized for mental health reasons.I have been diagnosed with PTSD.My psychiatric medication was changed recently or will change during the study.I have been diagnosed with bipolar disorder or schizophrenia.You have used cannabis more than 13 days in the past month, which means using it on at least 3 days every week.You have expressed thoughts or intentions of hurting yourself or others.You have a problem with using drugs or alcohol, except for cannabis (marijuana) or tobacco.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Contingency Management (CM)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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