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Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study

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ClinicalTrials.gov Identifier: NCT03008005
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Christine A. Rabinak, Wayne State University

Brief 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.

Condition or disease Intervention/treatment Phase
PostTraumatic Stress Disorder Drug: Placebo Oral Capsule Drug: Dronabinol Cap 5 milligrams (MG) Drug: Dronabinol Cap 10 milligrams (MG) Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of THC on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Placebo Comparator: Placebo Oral Capsule

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.

One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Placebo Oral Capsule
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.
Other Name: sugar pill

Experimental: Dronabinol Cap 5 milligrams (MG)

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.

One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Dronabinol Cap 5 milligrams (MG)
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.
Other Name: Marinol

Experimental: Dronabinol Cap 10 milligrams (MG)

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.

One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Dronabinol Cap 10 milligrams (MG)
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 Name: Marinol




Primary Outcome Measures :
  1. Brain Measures [ Time Frame: Visits 3-5: For approximately 60 mins each visit ]
    functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) percent signal change within region of interests [amygdala; ventromedial prefrontal cortex; hippocampus].

  2. Psychophysiology [ Time Frame: Visits 2-5: For approximately 30 mins during Visit 2 and 60 mins during Visits 3-5. ]
    Skin conductance response (SCR): change in SCR [peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation].

  3. Expectancy Ratings [ Time Frame: Visits 2-5: For approximately 30 minutes during Visit 2 and 60 minutes during Visits 3-5. ]
    To assess the expected likelihood that an aversive cue (e.g. noise burst or shock) will occur or not based on while slide was shown, participants will repeatedly rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented; 2 = certain that the aversive cue will not be presented; 3 = uncertain whether the aversive cue will be presented].


Secondary Outcome Measures :
  1. Subjective Units of Distress (SUDS) [ Time Frame: Visits 2-5: taken at three time points throughout the tasks: before the task begins, in the middle of the task, and at the end of the task. Each rating takes no more than 5 seconds ]
    Subjective Units of Distress (SUDS): used to measure fear ratings/"subjective" anxiety on a scale from 0-100

  2. Visual Analogue Scale of Mood [ Time Frame: Visit 3: These measures are collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards. This rating takes approximately 5 minutes to complete. ]
    Visual Analog Scales (VAS): Subjective ratings of mood and drug effects on a 0-100.

  3. Drug Effects Questionnaire [ Time Frame: Visits 3 & 4: During Visit 3, collected immediately before capsule ingestion (Time 0), and 30, 60, 90, 120, 150, 180, and 240 minutes and 8 hours. Will also be collected 24 hours after drug administration on Visit 4. ]
    Drug Effects Questionnaire (DEQ): Subjective ratings of drug effects on from 1-5 on the following scales: "Feel", "High", and "Like".

  4. Addiction Research Center Inventory [ Time Frame: Visit 3: These measures are collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards. This rating takes approximately 5 minutes to complete. ]
    Addiction Research Center Inventory (ARCI): A standardized questionnaire for assessing subjective effects of psychoactive drugs. Used to differentiate drug effects from placebo.

  5. State-Trait Anxiety Inventory [ Time Frame: Visit 3: These measures are collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards. This rating takes approximately 5 minutes to complete. ]
    Spielberger Trait/State Anxiety Inventory (STAI): Measure of trait and state anxiety.

  6. End of Session Questionnaire [ Time Frame: Visit 3: Completed at the end of Visit 3 (240 min post drug ingestion). Takes approximately 2 minutes to complete. ]
    Participants will complete the End of Session Questionnaire (ESQ), which includes question regarding overall drug effects during the session and asks participants to indicate whether they think they received active drug or placebo.

  7. Heart Rate [ Time Frame: Visit 3: Heart rate is collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards. This assessment takes approximately 1 minute. ]
    Heart rate will be collected at regular intervals throughout Visit 3.

  8. Blood Pressure [ Time Frame: Visit 3: Blood pressure is collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards. This assessment takes approximately 1 minute. ]
    Blood pressure will be collected at regular intervals throughout Visit 3.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008005


Contacts
Contact: Farrah Elrahal (313) 577-5404 felrahal@wayne.edu

Locations
United States, Michigan
Eugene Applebaum College of Pharmacy and Health Sciences Recruiting
Detroit, Michigan, United States, 48201
Contact: Farrah Elrahal    313-577-5404    felrahal@wayne.edu   
Principal Investigator: Christine A. Rabinak, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Christine A. Rabinak, PhD Wayne State University

Responsible Party: Christine A. Rabinak, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03008005     History of Changes
Other Study ID Numbers: 1R61MH111935-01 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists