Trial record 19 of 284 for:    Open Studies | "Stress Disorders, Post-Traumatic"

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Christine A. Rabinak, University of Michigan
ClinicalTrials.gov Identifier:
NCT02069366
First received: February 18, 2014
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 Intervention
Post-Traumatic Stress Disorder
Drug: Dronabinol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Brain Measures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    functional magnetic resonance imaging (fMRI) BOLD percent signal change within region of interests [amygdala; ventromedial prefrontal cortex; hippocampus].

  • Psychophysiology [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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].

  • Expectancy Ratings [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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:
  • Subjective Units of Distress (SUDS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Subjective Units of Distress (SUDS): used to measure fear ratings/"subjective" anxiety on a scale from 0-100; 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.

  • Mood & Drug Effect Questionnaires [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    (1) Visual Analog Scales (VAS); and (2) Drug Effects Questionnaire (DEQ); (3) Addiction Research Center Inventory (ARCI); (4) Spielberger Trait/State Anxiety Inventory (STAI). At completion of the extinction session, participants will complete the End of Session Questionnaire (ESQ). These measures are collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards, unless otherwise specified (e.g., DEQ will also be collected at 90, 150min, 8 hours and 24 hours, ESQ only at 240 min).

  • Physiological [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Heart rate and blood pressure will be collected at regular intervals throughout Visit 3 [immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards].


Estimated Enrollment: 120
Study Start Date: May 2014
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (7.5mg) or placebo (PBO) approximately two hours prior to fMRI scanning and task performance in 40 patients with PTSD, 40 trauma-exposed controls without PTSD (TEC), and 40 non-exposed healthy controls (HC).

Within each of the three groups half of the participants will receive dronabinol and the other half will received placebo to create the following 6 groups:

  1. PTSD-dronabinol (20)
  2. PTSD-placebo (20)
  3. TEC-dronabinol (20)
  4. TEC-placebo (20)
  5. HC-dronabinol (20)
  6. HC-placebo (20)
Drug: Placebo
Placebo is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive placebo.
Other Name: sugar pill
Active Comparator: Dronabinol

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (7.5mg) or placebo (PBO) approximately two hours prior to fMRI scanning and task performance in 40 patients with PTSD, 40 trauma-exposed controls without PTSD (TEC), and 40 non-exposed healthy controls (HC).

Within each of the three groups half of the participants will receive dronabinol and the other half will received placebo to create the following 6 groups:

  1. PTSD-dronabinol (20)
  2. PTSD-placebo (20)
  3. TEC-dronabinol (20)
  4. TEC-placebo (20)
  5. HC-dronabinol (20)
  6. HC-placebo (20)
Drug: Dronabinol
Dronabinol (7.5mg) is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive dronabinol.
Other Name: Marinol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for All Participants:

  • Able to give informed consent
  • Physically and neurologically healthy [confirmed by a comprehensive medical history]
  • Age between 21-45 years old
  • Right-handed

Inclusion Criteria for Participants with PTSD:

  • Current PTSD diagnosis [related to civilian trauma]

Inclusion Criteria for Trauma-Exposed Participants without PTSD:

  • Experience with a civilian trauma without a PTSD diagnosis
  • Free of a lifetime Axis I or Axis II diagnosis

Inclusion Criteria for Non-Trauma-Exposed Healthy Participants:

  • Free of a lifetime Axis I or Axis II diagnosis

Exclusion Criteria for All Participants:

  • Clinically significant medical or neurological condition
  • Less than a high school education
  • Lack of fluency in English
  • Night shift work
  • Currently pregnant; planning pregnancy; or lactating
  • Unwilling/unable to sign informed consent document
  • Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia)
  • 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 study participation
  • Positive urine drug screen and/or alcohol breathalyzer
  • 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]
  • Participation in an experiment involving white noise bursts or shocks in the last 6 months

Exclusion Criteria for Participants with PTSD:

  • Primary comorbid anxiety disorder (defined by which disorder was the more debilitating and clinically salient)
  • Life history of bipolar disorder, schizophrenia, or presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
  • Current or in the past 6 months alcohol/drug abuse of dependence
  • Current or in the past 6 months major depressive disorder
  • Current suicidal ideation
  • Diagnosis of an Axis II personality disorder
  • Concomitant treatments with psychotropic/psychoactive medication [including beta-adrenergic blockers, selective serotonin reuptake inhibitor (SSRI), benzodiazepines, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants, lithium, antiepileptic/anticonvulsants, neuroleptics/antipsychotics, etc.) or in the past two weeks [8 weeks for fluoxetine and 4 weeks for MAOIs) before screening (Visit 1)
  • currently receiving exposure-based therapy for PTSD

Exclusion Criteria for Trauma-Exposed Participants without PTSD and Non-Trauma Exposed Healthy Participants:

  • Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069366

Contacts
Contact: Christine A Rabinak, PhD 734-232-0269 thc.volunteer@umich.edu

Locations
United States, Michigan
Rachel Upjohn Building, East Medical Campus Not yet recruiting
Ann Arbor, Michigan, United States, 48109-2700
Contact: Christine A. Rabinak, PhD    734-232-0269    thc.volunteer@umich.edu   
Principal Investigator: Christine A. Rabinak, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Christine A. Rabinak, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Christine A. Rabinak, Research Assistant Professor, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT02069366     History of Changes
Other Study ID Numbers: HUM00069772
Study First Received: February 18, 2014
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Post-Traumatic Stress Disorders
Dronabinol
Extinction
fMRI

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 21, 2014