CompletedPhase 1

Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

United States102 participantsStarted 2021-04-15

Plain-language summary

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between ages 18-60 * Willing and able to consent to study * Generally medically and neurologically healthy (including no evidence of intellectual disability or serious cognitive impairment that would interfere with task performance) * Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5) * Significant PTSD severity as indicated by CAPS-5 diagnosis and/or score \>= 25 of at least one month prior to study entry, PTSD is patient's primary concern Exclusion Criteria: * Positive urine pregnancy test prior to fMRI, self-reported current pregnancy during screening, or planning pregnancy * Currently breastfeeding/ lactating * MRI contraindications (e.g., ferrous metal in head/body) * Pervasive development disorder history * Traumatic brain injury (TBI) with current cognitive impairment related to TBI * Risk of harm to self or others that requires immediate intervention * Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide) * Lack of fluency in English * Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia * Exclusively left-handed (score of -100 on Handedness Questionnaire) * Current or past diagnosis of bipolar, schizophrenia spectrum, psychotic and related disorders * Current severe alcohol or substance …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain Measures

Timeframe: Through study completion, an average of 3 months.

Psychophysiology

Timeframe: Through study completion, an average of 3 months.

Expectancy Ratings

Timeframe: Through study completion, an average of 3 months.

PTSD Checklist (PCL-5)

Timeframe: Through study completion, an average of 3 months.

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)

Timeframe: Through study completion, an average of 3 months.

Subjective Units of Distress Scale (SUDS)

Timeframe: Through study completion, an average of 3 months.

Trial details

NCT IDNCT04080427

SponsorWayne State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Brain Measures

Timeframe: Through study completion, an average of 3 months.

Psychophysiology

Timeframe: Through study completion, an average of 3 months.

Expectancy Ratings

Timeframe: Through study completion, an average of 3 months.

PTSD Checklist (PCL-5)

Timeframe: Through study completion, an average of 3 months.

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)

Timeframe: Through study completion, an average of 3 months.

Subjective Units of Distress Scale (SUDS)

Timeframe: Through study completion, an average of 3 months.