Study of the Safety & Efficacy of Nabiximols Oromucosal Spray Versus

Status Withdrawn

Clinical Trial Summary

This study will be conducted to evaluate the efficacy of nabiximols for the treatment of symptoms of post-traumatic stress disorder (PTSD) in participants receiving selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy.

Clinical Trial Description

This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial includes a screening period of up to 28 days, an 8-week treatment period (comprising a 2-week titration phase and a 6-week maintenance phase), and a 2-week follow-up period. At screening (Visit 1), all participants will receive instructions on how to complete a writing exercise (Exposure Writing Exercise) related to their traumatic experience. Prior to the baseline visit (Visit 2), participants must complete an approximate 30-minute writing exercise outside of the trial site and should have re-read the write up at least once to be eligible for enrollment. Throughout the screening and treatment periods, the dose of SSRI/SNRI used as background therapy, if any, should remain unchanged. On Day 1, eligible participants will be randomly assigned to either nabiximols or placebo in a 1:1 ratio. Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose that relieves their most bothersome symptom of PTSD or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period. Health-related quality of life, safety, and tolerability will be evaluated during the treatment period. Participants who complete the trial will participate for a total of approximately 14 weeks (99 days), including the 28-day Screening period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04592159
Study type	Interventional
Source	Jazz Pharmaceuticals
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	February 1, 2021
Completion date	March 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04317820` - Deep Brain Reorienting in Post-traumatic Stress Disorder	N/A
Completed	`NCT05112003` - Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot	N/A
Recruiting	`NCT04518267` - Anger and Psychotrauma: Data From Military and Civilians
Completed	`NCT02502604` - Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder	N/A
Terminated	`NCT02234687` - A mGlu2/3 Agonist in the Treatment of PTSD	Phase 1
Completed	`NCT02256566` - Cognitive Training for Mood and Anxiety Disorders	N/A
Completed	`NCT01738308` - The Effects of Healing Touch on Post Operative Pediatric Patients	N/A
Completed	`NCT02213900` - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy	Phase 4
Terminated	`NCT02520726` - PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims	Phase 4
Completed	`NCT01437891` - Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)	N/A
Completed	`NCT01517711` - Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)	Phase 4
Completed	`NCT01199107` - Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)	Phase 3
Completed	`NCT01998100` - Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)	Phase 3
Completed	`NCT01231711` - Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention	Phase 1
Completed	`NCT00348036` - Group Intervention for Interpersonal Trauma	N/A
Completed	`NCT00838006` - Psychophysiologic Predictors of Post-deployment Mental Health Outcomes	N/A
Completed	`NCT00680524` - Telephone-based Care for OEF/OIF Veterans With PTSD	N/A
Completed	`NCT00525226` - Evaluating the Effects of Stress in Pregnancy	N/A
Completed	`NCT00158262` - Effect of Propranolol on Preventing Posttraumatic Stress Disorder	Phase 4
Completed	`NCT00127673` - Comparison of Two Treatments for Post-Traumatic Stress Disorder	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms