Why is this study being conducted?

The purpose of the study is to evaluate a potential new treatment, EMD-RX5, for symptoms of anxiety or stress in adults with chronic pain. EMD-RX5 is a CBD product derived from the non-psychoactive component of cannabis.

Almost a third of Australian adults with pain often experience temporary psychological distress. This can impact a person’s quality of life, taking them away from work and social activities. Symptoms of psychological distress, such as acute stress, anxiety or nervous tension, are particularly common in patients with chronic pain.

Mental disorder, finding answers, confusion concept.

Who is eligible to participate in this study?

Men and women aged 18-70 years who:

  • Have chronic pain
  • Are experiencing symptoms of anxiety or stress
  • Are not currently diagnosed with certain mental health disorders such as schizophrenia, bipolar disorder, major depressive disorder, (MDD), post traumatic stress disorder (PTSD), anxiety disorders (including generalised anxiety disorder, panic disorder, social anxiety disorder), obsessive compulsive disorder

Volunteers who express interest in participating in this study will be reviewed and contacted further as other study requirements must also be met in order to participate.

What happens during the study?

If you agree to take part, and the study is suitable for you, your participation in the study is expected to last for approximately 7 weeks. This will involve:

  • Screening – Participants will have a screening visit to confirm they are eligible. If the criteria is met, the participant will be assigned to a treatment group.
  • Treatment assignment – Each participant will be assigned by chance (like the flip of a coin) to either receive EMD-RX5 at a dose of either 50mg or 150mg, or to receive a matching placebo.
  • What you will need to do – Participation in this study will involve around 4 onsite clinic visits plus 2 telephone visits over 7 weeks.

Why should individuals consider participating in this study?

If a person is eligible to participate, his/her data may help the research team to study whether EMD-RX5 is effective for the treatment of symptoms of psychological distress when compared with a placebo. Researchers hope that by understanding this medication better, more effective treatments can be developed for patients that are experiencing symptoms of psychological distress.

Participation in this study is completely voluntary, and participants can decide to withdraw at any time.

Eligible participants will be reimbursed for their time and travel associated with each study visit. If you would like to register your interest, please do so on the Evrima (external to Griffith University) platform.

If you’re interested

to be redirected to their website for pre-screening.

All study visits will be completed at the Griffith University Clinical Trial Unit on the Gold Coast.

For further information please contact Clinical Trial Coordinator, Taryn Houghton +61 7 5678 0285 or email: [email protected]