NCT04592159

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

A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Nabiximols	oromucosal spray
DRUG	Placebo	oromucosal spray

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-10-19
• Last updated: 2022-06-03