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

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Treatments: Dronabinol

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).