Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
Condition: PostTraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Placebo Oral Capsule; Dronabinol Cap 5 milligrams (MG); Dronabinol Cap 10 milligrams (MG)
Intervention description: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.; Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.; Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
Intervention MeSH terms: Dronabinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

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:

          -  Able to give informed consent

          -  Right-handed

          -  Age between 18-50 years old,

          -  Physically and neurologically healthy [confirmed by a comprehensive medical history]

          -  Current PTSD diagnosis

        Exclusion Criteria:

          -  clinically significant medical or neurologic condition or neurocognitive dysfunction
             that would affect function and/or task performance and/or interfere with the study
             protocol

          -  any current (or within past 2 months) medical condition requiring medication that
             would interact with dronabinol or interfere with the study protocol

          -  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

          -  positive drug screen or alcohol breathalyzer

          -  unwilling/unable to sign informed consent document

          -  currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women)

          -  under 18 or over 50 years of age

          -  traumatic brain injury (as defined by The American Congress of Rehabilitation as a
             person who has had a traumatically induced physiological disruption of brain function
             (i.e., the head being struck, the head striking an object, and/or the brain undergoing
             an acceleration/deceleration movement (i.e., whiplash) without direct external trauma
             to the head), as manifested by at least one of the following: any loss of
             consciousness; any loss of memory for events immediately before or after the injury;
             any alteration in mental status at the time of the incident; or focal neurological
             deficits that may or may not be transient)

          -  inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as
             determined by self-report and/or a preliminary session in a mock scanner

          -  left-handed;

          -  presence of ferrous-containing metals within the body (e.g., aneurysm clips,
             shrapnel/retained particles)

          -  anticipation of a required drug test in the 4 weeks following the study.

          -  current diagnosis of a mood, anxiety, or other disorder that is more clinically
             salient than PTSD

          -  current moderate or severe alcohol/drug use disorder or in the past 8 weeks

          -  current or past diagnosis of bipolar and other related disorders, schizophrenia
             spectrum, or other psychotic disorders

          -  concomitant treatments with medication known to have drug interactions with
             dronabinol, such as, central nervous system depressants (barbiturates,
             benzodiazepines, buspirone, lithium, etc) and anticholinergic agents (atropine,
             scopolamine, antihistamines, etc).