RecruitingPhase 3ACTRN12623000870651

Investigating the effects of a cannabis-based medication on sleep problems in chronic pain

Long-term effects of a cannabis-based medication on insomnia in chronic back pain: a randomized crossover trial

Sponsor

UNIVERSITY OF AUCKLAND

Enrollment

20 participants

Start Date

Oct 1, 2025

Study Type

Interventional

Conditions

Insomnia Chronic Pain

Summary

our study will assess the effectiveness of a New Zealand-produced CBM Helius Full- Spectrum THC 10: CBD 10 . We plan to run a study to compare the long-term effectiveness of this CBM with that of placebo in improving sleep in patients with chronic back pain over a six-month period. In total, 20 participants who suffer from chronic back pain and significant insomnia will be recruited. They will receive three months of CBM followed by three months of placebo, or vice versa (in random order). Neither the investigators nor the participants will be aware of which medication is which. During the study, the drug's effect on sleep and pain will be assessed using simple questionnaires and a wrist device (called an actigraph) to monitor sleep. The results of this study will help us to understand the place of CBM in reducing insomnia in patients with chronic pain.

Eligibility

Sex: Both males and femalesMin Age: 25 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic back pain and insomnia often occur together and can make each other worse — poor sleep makes pain harder to tolerate, and pain makes it harder to sleep. This study is testing whether a cannabis-based medication (CBM) containing equal parts THC and CBD can improve sleep in people who have both chronic back pain and significant insomnia, compared to a placebo. Twenty participants will each take three months of the cannabis medication followed by three months of placebo, or vice versa, in random order. Neither participants nor researchers will know which is which during the study (a double-blind design). Sleep quality and pain levels will be tracked using questionnaires and a wrist-worn device called an actigraph that monitors sleep patterns at home. You may be eligible if you are aged 25 or older, have chronic back pain without nerve-related symptoms, have an insomnia severity score above a certain threshold, and have had a stable treatment regimen for at least three months. People currently using cannabis products, those with a significant mental health or substance use history, or those who are pregnant are not eligible. The study is run by the University of Auckland.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This will be a randomised, double-blind, placebo-controlled crossover study on the efficacy of the study medication, a NZ-produced Cannabis-Based Medication (CBM) in treating insomnia in patients wit

This will be a randomised, double-blind, placebo-controlled crossover study on the efficacy of the study medication, a NZ-produced Cannabis-Based Medication (CBM) in treating insomnia in patients with chronic back pain. The study will be run over 196 days (84 days per arm) in the Bay of Plenty. The Chief Investigator (CI), a Specialist Pain Medicine Physician (SPMP), will undertake the study, including data collection and analysis. Investigational Medicinal product (IMP) Helius THC10:CBD10 Full Spectrum. Oral liquid prescribed in 30 ml bottles with a child-proof lid and a 1 ml graduated oral syringe. The formulation uses a medium-chain triglyceride (MCT) carrier oil. The subjects will be given one bottle at a time, which will last approximately 30 days. Study participants will be asked to take the medication about one hour before bedtime. Subjects will be asked to start at 0.2 ml and titrate up by 0.2 ml per day to a maximum dose of 1.0 ml per night, with the aim of balancing positive effect of sleep against any adverse effects. The IMP will be stored with Helius or study pharmacy before dispensing to participants. Procedure Participants will be provided with an actigraphic device (Motion watch 8- CamNtech) for the duration of the study, which will be used to assess objective sleep parameters. Following 14 days of baseline monitoring, participants will collect their first bottle of the IMP (CBM or placebo) from the trial pharmacist. Participants will collect a new bottle approximately every 30 days (i.e., approximately three bottles per patient per arm of study). Participants will be asked to take the IMP one hour before sleep, and to titrate it up in 0.2 ml increases per night to a maximum dose of 1 ml (equivalent to 10mg THC). Participants who are otherwise eligible, but whose treatment regimen has changed in the previous three months, will be allowed to enrol once their treatment has been stable for 12 weeks. Participants will be monitored regularly during the baseline period and for the first 14 days of the study , and then at weekly intervals. They will attend a clinic at approximately 28-day intervals until completion of first leg of study at 84 days. Participants will enter a two-week washout period, followed by a second arm using the IMP that they did not receive in the first arm (CBM or Placebo), with otherwise identical research procedures. Adherence will be monitored with urine testing at each clinic visit (every 28 days).