Urgent Access to Effective Treatments to End the Agony of Cluster Headaches

Cluster headache is one of the most excruciatingly painful conditions known to medicine, compared by those suffering to having a red-hot ice pick driven into the eye. It is also called "suicide headache" because some patients choose to end their lives to escape the pain. There is no known cure, and standard existing medical options are unable to consistently and reliably prevent or abort attacks. An estimated 11,000 Australian adults endure this unbearable pain every year.

Countless patients have reported previously unattainable relief using certain compounds of the indoleamine chemical family, which interact with serotonin receptors.^[1] Psilocybin, LSD, 5-MeO-DALT and BOL-148 (a non-hallucinogenic derivative of LSD) have been shown to be effective in preventing attacks, and N,N-DMT has been found^[2] to abort attacks within seconds and also have some preventative effects, even at sub-hallucinogenic doses. These are not isolated anecdotes: hundreds of patients have reported these effects in published scientific surveys, some clinical trials support these claims, and limited use in clinical settings has also demonstrated the effectiveness. In patient support groups and in conferences organised by a major patient advocacy group, patients relate the successes they have had in ending their pain through the use of these substances.

Based on an analysis of all the evidence, we have no doubt at all that these substances have medical value in preventing the excruciating pain of cluster headache where other therapies have failed. Although caution must always be exercised, these compounds are generally regarded as safe substances with low toxicity.^[3]

None of these substances has yet been approved for the medical treatment of cluster headache. Conducting large-scale clinical trials is complicated by the difficulty to recruit patients with this relatively rare condition, and the lack of funding to study these non-proprietary compounds.

In Australia, there are currently no established compassionate use provisions for these compounds to treat cluster headache. While Australia made history in July 2023 by becoming the first country to permit limited medical use of psilocybin by rescheduling it from Schedule 9 (Prohibited Substance) to Schedule 8 (Controlled Drug), this access is strictly limited to psychiatrists treating patients with treatment-resistant depression. No such provision exists for cluster headache patients, and other psychedelics like LSD and DMT remain Schedule 9 substances with no authorised medical use. The Special Access Scheme theoretically provides a pathway for case-by-case approvals, but in practice, approvals for these compounds to treat cluster headache are essentially nonexistent. Even in the Australian Capital Territory, where personal possession of small amounts of psychedelics has been decriminalised, there exists no legal avenue for medical treatment. The result is that many Australians suffering from this excruciating condition are forced to either rely on conventional treatments that often fail, or risk criminal penalties by seeking relief through unofficial channels. Meanwhile, countries like Switzerland have established compassionate use provisions allowing physicians to prescribe psilocybin and LSD to cluster headache patients, and Canada has begun authorizing individual cases under its Special Access Program.^[4]

This situation demands the same urgency as providing anaesthesia for major surgical procedures.

We call on the Australian government to institute the following measures:^[5]