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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The total time that for each participant involved in this study is 5 visits, as outlined
      below:

      Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential
      participant will learn about the study procedures, sign the informed consent documents, and
      fill out a packet of forms that ask about his or her race and ethnic background, use of drugs
      and alcohol and physical and mental health.

      Visit 2: Behavioral Tests: During this visit the participant will complete several computer
      tasks, and the study staff will be measuring reaction time and psychophysiological
      measures.The tasks that the participant will perform will show three different images and an
      aversive stimulus (e.g. loud burst of noise or animated snake) may follow one image most of
      the time, while the other images may never be followed by the aversive cue. The participant
      will need to try to predict whether the aversive cue will occur or not based on which image
      is shown and will be asked to repeatedly rate on a scale how likely it is that he or she
      thinks an aversive cue will occur after each image. Lastly, during the session the
      participant will also be asked to report his or her level of anxiety on a scale from 0 to
      100.

      Visit 3: Behavioral Tests with Drug or Placebo and Magnetic Resonance (MR) scan: For safety
      reasons participant will not be allowed to take any drugs for at least 24 hours before this
      visit, and should not use marijuana for at least 2 weeks before. Participants will be
      required to pass a urine drug test (and pregnancy test for women) and breathalyzer test
      before being allowed to continue with this visit. The participant will also not be allowed to
      drive himself or herself home from this visit, so he or she should arrange a friend or family
      member to pick him or her up or a taxi can be called by our research staff.

      The participant will view the same images he or she did on the previous day (Visit 2), and
      may experience the same aversive stimulus as during Visit 2. The participant will again be
      asked to rate how much he or she expects to experience the aversive stimulus after each image
      and he or she will also be asked to report his or her level of anxiety on a scale from 0 to
      100. However, about 2 hours before the task begins, the participant will be asked to swallow
      a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill).
      Dronabinol is a Food & Drug Administration (FDA) approved drug and the doses (5mg or 10mg;
      one time) are unlikely to have any effects that last beyond the duration of the study visit.
      About every 30 minutes after taking the pill, the participant will fill out some
      questionnaires about mood and how he or she is feeling at the moment.

      Visit 4: Behavioral Tests and MR scan: This visit will be very similar to Visit 2.
      Participants will participate in the same type of task inside the MR scanner, while the study
      staff measures reaction time and psychophysiological responding and brain activation.
      Participants will view the same images he or she did previously, and may experience the same
      aversive stimulus as during Visit 2. Participants will again be asked to rate how much they
      expect to experience the aversive stimulus after each image and will also be asked to report
      their level of anxiety on a scale from 0 to 100.

      Visit 5: Behavioral Tests and MR scan: This visit will occur approximately 1 week after Visit
      4 and will have the same procedure. Participants will participate in the same type of task
      inside the MR scanner, while the study staff measures reaction time and psychophysiological
      responding and brain activation. Participants will again be asked to rate how much they
      expect to experience the aversive stimulus after each image and will also be asked to report
      their level of anxiety on a scale from 0 to 100.
    

Intervention name(s): Placebo Oral Capsule; Dronabinol Cap 5 milligrams (MG); Dronabinol Cap 10 milligrams (MG)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): sugar pill; Marinol; Marinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science