Cannabinoid Control of Fear Extinction Neural Circuits in Humans
Condition: Healthy Participants
Intervention: Dronabinol; Placebo
Intervention description: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol.; Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo.
Intervention MeSH terms: Dronabinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Marinol; Dronabinol; Fear extinction; Healthy volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 21-45

          2. right-handed

          3. free of lifetime diagnosis of Axis I psychiatric disorder

          4. must be able to given informed consent

          5. must be medically and neurologically healthy.

        Exclusion Criteria:

          1. any current medical condition requiring psychoactive/psychotropic medication or
             medication that would interact with dronabinol or interfere with study procedures

          2. 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.)

          3. any current or past Axis I psychiatric disorder, including alcohol/substance abuse or
             dependence disorder

          4. less than a high school education

          5. lack of fluency in English

          6. night shift work

          7. currently pregnant or planning pregnancy or lactating (women)

          8. unwilling/unable to sign informed consent document

          9. inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as
             determined by self-report and a preliminary session in a mock scanner

         10. left-handed

         11. presence of ferrous-containing metals within the body (e.g., aneurysm
             clips,shrapnel/retained particles)

         12. under 21 or over 45 years of age

         13. anticipation of a required drug test in the 4 weeks following the study. No vulnerable
             participant populations will be included in this study

         14. participation in an experiment involving shocks in the last 6 months.