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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-treatment (approximately six weeks)
Awards & highlights
FOCUS Trial 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.Check my eligibility
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.See study design
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.
FOCUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD.
FOCUS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0289671210%
Drowsiness
10%
Weakness
10%
Muscle Aches
10%
Blurry Vision
10%
Fatigue
5%
Symptoms of Congestive Heart Failure
5%
Skin Rash
5%
Difficulty Walking
5%
Asthma Attack
5%
Upper Respiratory Infection
5%
Vomiting
5%
Increased Urination
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: DC Plus CM, With Modafinil
Phase 2: ACT Plus CM, With Modafinil
Phase 2: DC Plus CM Only
Phase 2: DC Plus CM, With Placebo
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
FOCUS 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
~420
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,244 Total Patients Enrolled
Jean C Beckham, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
313 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current size of the sample population for this medical experiment?
"Absolutely. According to clinicaltrials.gov, this medicinal trial is still seeking participants; it was initially announced on January 26th 2022 and the latest update came out February 3rd 2022. The research demands 40 volunteers from a single medical centre."
Answered by AI
Are there any existing vacancies for this research endeavor?
"As stated on clinicaltrials.gov, this experiment is actively searching for trial volunteers. The original posting was made on the 26th of January 2022 and an update occurred shortly afterwards on February 3rd."
Answered by AI
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