N/A
N=86
Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder
Post-Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02069366 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Brain Measures — -0.08; 0.27; 0.02; 0.03 arbitrary units — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dronabinol (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Wayne State University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Measures |
-0.08; 0.27; 0.02; 0.03; -0.05; -0.09 | >0.05 |
| PRIMARY Expectancy Ratings |
1; 3; 4; 2; 3; 4 | >0.05 |
| SECONDARY Subjective Units of Distress (SUDS) |
3.44; 2.5; 2.83; 1.79; 3.15; 1.92 | >0.05 |
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 development 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.
Eligibility Criteria
Inclusion Criteria for All Participants:
- Able to give informed consent
- Physically and neurologically healthy [confirmed by a comprehensive medical history]
- Age between 21-45 years old
- Right-handed
Inclusion Criteria for Participants with PTSD:
- Current PTSD diagnosis [related to civilian trauma]
Inclusion Criteria for Trauma-Exposed Participants without PTSD:
- Experience with a civilian trauma without a PTSD diagnosis
- Free of a lifetime Axis I or Axis II diagnosis
Inclusion Criteria for Non-Trauma-Exposed Healthy Participants:
- Free of a lifetime Axis I or Axis II diagnosis
Exclusion Criteria for All Participants:
- Clinically significant medical or neurological condition
- Less than a high school education
- Lack of fluency in English
- Night shift work
- Currently pregnant; planning pregnancy; or lactating
- Unwilling/unable to sign informed consent document
- Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia)
- Left-handed
- Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- Under 21 or over 45 years of age
- Anticipation of a required drug test in the 4 weeks following study participation
- Positive urine drug screen and/or alcohol breathalyzer
- 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]
- Participation in an experiment involving white noise bursts or shocks in the last 6 months
Exclusion Criteria for Participants with PTSD:
- Primary comorbid anxiety disorder (defined by which disorder was the more debilitating and clinically salient)
- Life history of bipolar disorder, schizophrenia, or presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
- Current or in the past 6 months alcohol/drug abuse of dependence
- Current or in the past 6 months major depressive disorder
- Current suicidal ideation
- Diagnosis of an Axis II personality disorder
- Concomitant treatments with psychotropic/psychoactive medication [including beta-adrenergic blockers, selective serotonin reuptake inhibitor (SSRI), benzodiazepines, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants, lithium, antiepileptic/anticonvulsants, neuroleptics/antipsychotics, etc.) or in the past two weeks [8 weeks for fluoxetine and 4 weeks for MAOIs) before screening (Visit 1)
- currently receiving exposure-based therapy for PTSD
Exclusion Criteria for Trauma-Exposed Participants without PTSD and Non-Trauma Exposed Healthy Participants:
- Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]
Data sourced from ClinicalTrials.gov (NCT02069366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.