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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001319763

Enrollment

160

Registered

2022-10-12

Start date

2023-01-27

Completion date

2023-07-28

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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-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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

- 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 criteria

- 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.

Outcome results