Phase 4
Completed N=50
Cannabinoid Control of Fear Extinction Neural Circuits in Humans
Healthy Participants
Source: ClinicalTrials.gov NCT02472847 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI) — 0.1631; 0.5079 parameter estimates (arbitrary units)
Summary
The goal of the current proposal is to investigate the effects of a cannabinoid drug on the memory of extinguished fear in humans and the brain circuitry important for the recall of extinction learning. The investigators findings will translate previous discoveries from animal studies to humans and increase their understanding of the neurobiological mechanisms supporting retention of extinction memory. This proof-of-concept study is a critical translational first step towards the development of cannabinoid modulators as an adjunctive strategy to exposure-based therapies to augment extinction learning and prevent the return of fear memories in patients with post-traumatic stress and other anxiety disorders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI) |
0.1631; 0.5079 | — |
Eligibility Criteria
Inclusion Criteria
- age 21-45
- right-handed
- free of lifetime diagnosis of Axis I psychiatric disorder
- must be able to given informed consent
- must be medically and neurologically healthy.
Exclusion Criteria
- any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol or interfere with study procedures
- current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substance (Dronabinol /Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide.)
- any current or past Axis I psychiatric disorder, including alcohol/substance abuse or dependence disorder
- less than a high school education
- lack of fluency in English
- night shift work
- currently pregnant or planning pregnancy or lactating (women)
- unwilling/unable to sign informed consent document
- inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and a preliminary session in a mock scanner
- 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 the study. No vulnerable participant populations will be included in this study
- participation in an experiment involving shocks in the last 6 months.
Data sourced from ClinicalTrials.gov (NCT02472847). 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. Informational only — not medical advice.