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THC for Post-Traumatic Stress Disorder
Study Summary
This trial is studying how cannabinoids (a type of drug) are related to the processing of fear signals and the experience of emotions and fear. The goal is to see if this could lead to new treatments for anxiety or fear-based disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with bipolar disorder, schizophrenia, or any related mental health conditions.You have a history of developmental disorders that affect your ability to communicate and interact with others.You must be right-handed or ambidextrous (able to use both hands equally).You are currently breastfeeding a baby.I am generally healthy with no serious brain health issues affecting my thinking or daily tasks.You have experienced a traumatic event that meets certain criteria and has been identified through a checklist.I have cognitive issues due to a past brain injury.I am not taking any daily medication that severely interacts with dronabinol.You are currently dealing with a serious alcohol or drug addiction.I am between 18 and 60 years old.I feel anxious in small, enclosed spaces.I am allergic or have had bad reactions to cannabis-related substances or ingredients in cannabinoid medications.You have been diagnosed with a severe case of PTSD with a score of 25 or higher on the CAPS-5 test and it has been your main concern for at least a month before the study.You are not able to speak English fluently.You have a mental health condition like depression or anxiety that started before you developed PTSD.I am currently pregnant or planning to become pregnant.
- Group 1: Dronabinol 7.5 milligram oral capsule
- Group 2: Placebo capsule
- 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
How many individuals are being included in this medical experiment?
"Affirmative. As noted on clinicaltrials.gov, this medical trial is recruiting patients at the moment. The study was initially advertised on April 15th 2021 and underwent its last update March 10th 2022. 100 participants are needed from one single centre."
Does this clinical trial cater to individuals over the age of thirty?
"This medical trial is recruiting individuals aged 18 to 60."
Am I able to join this experiment?
"This clinical trial is willing to accept 100 participants with a documented diagnosis of PTSD, ranging in age from 18-60. To be eligible for the study, individuals must present an exposure to Criterion A stressor as identified by CAPS-5 and LEC-5; demonstrate general medical health and neurological functionality that does not impede task completion; have experienced significant PTSD severity within one month prior to entering the program; and report PTSD as their primary concern."
What prior research exists about the effects of Dronabinol 7.5 milligram oral capsules?
"Presently, 6 clinical trials for Dronabinol 7.5 milligram oral capsules are in Phase 3; out of a total 38 ongoing studies. Most of these are located within Belmont, Massachusetts but data indicates that there is an expansive network spanning 90 locations researching this medication."
What are common therapeutic applications of Dronabinol 7.5 milligram oral capsules?
"Dronabinol 7.5 milligram oral capsule is frequently administered to manage weight loss and the inadequate response of conventional therapy, pharmacotherapy, or appetite suppression."
What are the potential hazards associated with a 7.5 milligram dose of Dronabinol oral capsules?
"The safety of the Dronabinol 7.5 milligram oral capsule was judged to be a 1 on our scale due to this being an early phase trial with limited data supporting efficacy and safety."
What key outcomes is this trial seeking to determine?
"The primary metric for this trial is the Subjective Units of Distress Scale (SUDS). Secondary outcomes include evaluations with State-Trait Anxiety Inventory (STAI), End of Session Questionnaire (ESQ) and Drug Effects Questionnaire (DEQ). The STAI measures both state anxiety, which includes "I am tense; I am worried" and "I feel calm; I feel secure", as well as trait anxiety such as: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person". Whereas ESQ consists of 5 queries on capsule effects, DEQ surveys"
Are there open spots for participation in this investigation?
"Data on clinicaltrials.gov verifies that this trial, which was first established on April 15th 2021, is actively recruiting participants. The study's details were most recently updated in March of 2022."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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