Topics

Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

2019-09-12 02:34:41 | BioPortfolio

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 treatment 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.

Description

The total time commitment estimated per participant 18 study visits. This is broken down 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: Pre-Treatment Behavioral Tests and and Magnetic Resonance (MR) Scan: 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: Pre-Treatment 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.

Visits 4 & 5: Prolonged Exposure (PE) Sessions 1 & 2: These sessions will consist of psychoeducation that includes discussion or reactions to trauma , treatment rationale, breathing retraining, and review of SUDS to assess level of distress from 0 to 100 (100=extreme anxiety/distress) when facing fears. One session occurs weekly across 2 weeks.

Visits 6-14: PE Sessions 3-11: These sessions will consist of repeated exposures to trauma memories (imaginal exposure) and avoided situations (in vivo exposure). As is standard, patients will also practice exposures (e.g., listen to tapes of imaginal exposure, carry out in vivo exposure) outside of PE sessions as "homework". At exposure-focused sessions (Sessions 3-11) either THC or PBO will be administered just before the session. One session occurs weekly across 8 weeks.

Visit 15: PE Session 12 [Post-treatment Assessment]: This session will include a review of therapeutic gains/relapse prevention/assessments.

Visit 16: Post-Treatment 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 17: Post-Treatment Behavioral Tests and MR Scan: This visit will be very similar to Visit 3. 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 3. 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 18: 3-Month Follow-Up Treatment Assessment: This session is similar to Visit 15 and will include review of therapeutic gains/relapse prevention/assessments.

Study Design

Conditions

Posttraumatic Stress Disorder

Intervention

Placebo capsule, Dronabinol 7.5 milligram oral capsule

Location

Eugene Applebaum College of Pharmacy and Health Sciences
Detroit
Michigan
United States
48201

Status

Not yet recruiting

Source

Wayne State University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-12T02:34:41-0400

Clinical Trials [3723 Associated Clinical Trials listed on BioPortfolio]

Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule

Zhi Kang Capsule functions for hemostasis and detumescence and can be used for traumatic bleeding, uterine bleeding, hematemesis and hematochezia.This randomized controlled trial was condu...

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects

This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in he...

The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo....

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo...

The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients

The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effec...

PubMed Articles [11154 Associated PubMed Articles listed on BioPortfolio]

Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach.

 Esophageal capsule endoscopy is reported to be insufficiently accurate to replace esophagogastroduodenoscopy (EGD) because the passage of the capsule through the esophagus is passive and precludes ...

Quantifying the value of orally delivered biologic therapies: A cost-effectiveness analysis of oral semaglutide.

Oral semaglutide, currently in phase three clinical trials, represents the first case of an oral biologic medication for type 2 diabetes in the form of a daily capsule. It provides similar efficacy co...

Contemporary Management of the Hip Capsule During Arthroscopic Hip Preservation Surgery.

The importance of the hip capsule and its effect on hip biomechanics, functional outcomes, and hip arthroscopy success rates has been demonstrated in recent studies. These results have led to a shift ...

Evaluation of Lens Capsule Stability Using Capsular Tension Ring, Iris Retractor, and Capsule Expander Using a Porcine Model With Zonular Dehiscence.

We evaluate the efficacy of capsular tension rings (CTRs), iris retractors (IRs), and capsule expanders (CEs) in stabilizing the lens capsule under different degrees of zonular dehiscence using a porc...

Understanding the Motion of Hard-shell Capsules in Dry Powder Inhalers.

The delivery of small drug particles from a dry powder inhaler (DPI) into the patient's peripheral airways requires the dispersion of the powder. In DPIs that contain a rotating pierced capsule, the c...

Medical and Biotech [MESH] Definitions

Inflammation of the synovial lining of a tendon sheath. Causes include trauma, tendon stress, bacterial disease (gonorrhea, tuberculosis), rheumatic disease, and gout. Common sites are the hand, wrist, shoulder capsule, hip capsule, hamstring muscles, and Achilles tendon. The tendon sheaths become inflamed and painful, and accumulate fluid. Joint mobility is usually reduced.

Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.

Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.

A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.

The sac enclosing a joint. It is composed of an outer fibrous articular capsule and an inner SYNOVIAL MEMBRANE.

More From BioPortfolio on "Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study"

Quick Search

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Stress
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...


Searches Linking to this Trial