← Back to Search

Cannabinoids

THC Group for Veterans (CBH Trial)

Q: Are patients currently being actively recruited for participation in this clinical trial?

According to clinicaltrials.gov, this research investigation is currently not in search of participants. Initially made public on 5/1/2024, the most recent update was done on 4/18/2024. It's worth noting that despite this trial being inactive in its recruitment phase, there are a total of 732 ongoing studies actively seeking eligible candidates presently.

Q: What are the principal goals that this medical study aims to achieve?

The objective of this investigation, to be evaluated at the pre-treatment visit and four post-treatment visits occurring one week, 3 months, 6 months, and 9 months after treatment initiation, is to monitor alterations in <a href="https://www.withpower.com/clinical-trials/ptsd">PTSD</a> diagnosis and its associated symptom intensity utilizing the PCL-5 evaluation. Additional goals include gauging levels of loneliness before and after treatment using UCLA's Three-Item Loneliness Scale (3-ILS), which measures social disconnection and feelings of isolation. Additionally, it aims to appraise historical instances of trauma both from childhood and throughout life prior to treatment commencement employing the ACE questionnaire for adults as well

Q: Can individuals who are older than 60 years be considered for participation in this study?

Participants aged between 19 and 69 are eligible for enrollment in this research study. Notably, there are a total of 124 trials focusing on individuals under the age of 18 and another 516 trials targeting those over the age of 65.

Phase 1 & 2

Waitlist Available

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet DSM-5 criteria for PTSD with symptoms of at least 6 months duration

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up biological samples will be collected at a pre-treatment (at the baseline visit); during the 12-week treatment phase (every two weeks during the treatment phase); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months po

Awards & highlights

CBH Trial Summary

This trial will test if cannabinoids can help veterans with PTSD and thoughts of suicide.

Who is the study for?

This trial is for veterans with PTSD who may also be using cannabis. It's designed to help those struggling with suicidal thoughts. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.Check my eligibility

What is being tested?

The study tests the effects of Cannabidiol (CBD) and Tetrahydrocannabinol (THC), components of cannabis, against a placebo to see if they can help treat PTSD in veterans. The participants will be randomly assigned to one of these treatments.See study design

What are the potential side effects?

While not specified here, CBD could cause tiredness, diarrhea, or changes in appetite/weight. THC might lead to increased heart rate, coordination issues, dry mouth or red eyes. Both can affect mood and mental state.

CBH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD and have had symptoms for at least 6 months.

CBH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing Suicidality over time using the C-SSRS assessment.

Assessing Suicidality throughout the study using the SBQ-R assessment.

Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.

+2 more

Secondary outcome measures

Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD.

Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires.

Assess demographics using a self-report assessment

+15 more

CBH Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: THC GroupExperimental Treatment1 Intervention

Cannabis with 2.5 mg THC; up to a maximum of 5 doses/day (max dose = 12.5 mg THC)

Group II: THC & CBD GroupExperimental Treatment2 Interventions

Cannabis with 2.5 mg THC and 2.5 mg CBD; up to a maximum of 5 doses/day (max doses = 12.5 mg THC and 12.5 mg CBD)

Group III: CBD GroupExperimental Treatment1 Intervention

Cannabis with 2.5 mg CBD; up to a maximum of 5 doses/day (max dose = 12.5 mg CBD)

Group IV: Placebo GroupActive Control1 Intervention

Cannabis with <1mg THC and <1mg CBD; up to a maximum of 5 doses/day (max dose = <5 mg THC and <5 mg CBD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

Tetrahydrocannabinol

2012

Completed Phase 2

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor

309 Previous Clinical Trials

108,560 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being actively recruited for participation in this clinical trial?

"According to clinicaltrials.gov, this research investigation is currently not in search of participants. Initially made public on 5/1/2024, the most recent update was done on 4/18/2024. It's worth noting that despite this trial being inactive in its recruitment phase, there are a total of 732 ongoing studies actively seeking eligible candidates presently."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The objective of this investigation, to be evaluated at the pre-treatment visit and four post-treatment visits occurring one week, 3 months, 6 months, and 9 months after treatment initiation, is to monitor alterations in PTSD diagnosis and its associated symptom intensity utilizing the PCL-5 evaluation. Additional goals include gauging levels of loneliness before and after treatment using UCLA's Three-Item Loneliness Scale (3-ILS), which measures social disconnection and feelings of isolation. Additionally, it aims to appraise historical instances of trauma both from childhood and throughout life prior to treatment commencement employing the ACE questionnaire for adults as well"

Answered by AI

Can individuals who are older than 60 years be considered for participation in this study?

"Participants aged between 19 and 69 are eligible for enrollment in this research study. Notably, there are a total of 124 trials focusing on individuals under the age of 18 and another 516 trials targeting those over the age of 65."

Answered by AI

Recent research and studies

Psychological AssessmentJournal

The Clinician-administered PTSD Scale for DSM–5 (CAPS-5): Development and Initial Psychometric Evaluation in Military Veterans.

Weathers, Frank W., Michelle J. Bovin, Daniel J. Lee, Denise M. Sloan, Paula P. Schnurr, Danny G. Kaloupek, Terence M. Keane, and Brian P. Marx. 2018. “The Clinician-administered PTSD Scale for DSM–5 (CAPS-5): Development and Initial Psychometric Evaluation in Military Veterans.”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/pas0000486.

Advances in Medical Education and PracticeJournal

US Veterans and Their Unique Issues: Enhancing Health Care Professional Awareness

Olenick, Maria, Monica Flowers, and Valerie Diaz. 2015. “US Veterans and Their Unique Issues: Enhancing Health Care Professional Awareness”. Advances in Medical Education and Practice. Informa UK Limited. doi:10.2147/amep.s89479.

The American Journal on AddictionsJournal

Posttraumatic Stress Disorder and Cannabis Use Characteristics Among Military Veterans with Cannabis Dependence

Boden, Matthew Tyler, Kimberly A. Babson, Anka A. Vujanovic, Nicole A. Short, and Marcel O. Bonn-Miller. 2013. “Posttraumatic Stress Disorder and Cannabis Use Characteristics Among Military Veterans with Cannabis Dependence”. The American Journal on Addictions. Wiley. doi:10.1111/j.1521-0391.2012.12018.x.

PharmacopsychiatryJournal