SuspendedPhase 3ACTRN12622001319763

A Phase III study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain

A multi-site, parallel-arm, randomised, double blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain

Sponsor

Emyria Ltd

Enrollment

300 participants

Start Date

Jan 27, 2023

Study Type

Interventional

Conditions

Psychological Distress

Summary

Symptoms of psychological distress, also described as acute stress, anxiety or nervous tension are particularly common in patients suffering chronic pain. EMD-RX5 is a cannabidiol (CBD) capsule. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. The purpose of this study is to determine whether EMD-RX5 improves symptoms of psychological distress in patients experiencing chronic pain.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria4

Chronic pain (defined as pain that has persisted for at least 3 months prior to date of consent)
Self-reported at least mild psychological distress symptoms as measured by a baseline DASS-21 anxiety symptom score 8 or more
If taking pain medications at the time of screening dose must be stable for at least one month prior to study screening
Women of childbearing potential and men with sexual partners of childbearing potential must confirm the use of at least one acceptable form of contraception to be used throughout study participation.

Exclusion Criteria6

Current diagnosis of mental health disorder as defined by DSM-5
Currently taking or has taken any psychotropic medications for treatment of mental health illness for one month prior to screening
Current suicidality or self-harm ideation
Pregnant females
History of drug or alcohol abuse within 6 months of screening as per investigator judgement or a positive urine drug screen for THC
Currently taking or has taken any cannabinoid products within 30 days of trial treatment.

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Interventions

The study will enrol 300 participants across 4 dosing arms. Participants will receive a daily oral dose of EMD-RX5 or matching placebo for 4 weeks. Active treatment arms as below: Arm A: 150mg EMD-R

The study will enrol 300 participants across 4 dosing arms. Participants will receive a daily oral dose of EMD-RX5 or matching placebo for 4 weeks. Active treatment arms as below: Arm A: 150mg EMD-RX5 CBD capsules (2x 50mg capsules in the morning, 1x 50mg capsule in the evening) Arm B: 50mg EMD-RX5 CBD capsules (1x 50mg capsules in the morning)