MAC’s Experience with Hallucinogenic Compounds
Interest in the use of psychedelic substances for the treatment of mental health disorders is increasing, although the processes that affect therapeutic change are not yet fully understood. A major challenge is that studies of hallucinogenic molecules requires meticulous resourcing design and execution.
MAC has been working on the design and execution of functional Psychiatry studies for over 30 years and has developed a strong and safe clinical offering to overcome the challenges. The infrastructure at MAC has developed to provide seamless delivery of full-service drug programs for complex CNS trials. From early stage development - provided by our MHRA accredited early phase Neuroscience centre of excellence - through to late phase protocols delivered across our network of fully equipped dedicated and experienced late phase research centres. MAC's translational medicine group are developing and validating a variety of psychedelic treatment protocols.
MAC has specific expertise in the sourcing and manufacturing of Home Office controlled drugs in conventional and alternative dosing regimens. We also have internal capabilities to manufacture and distribute controlled drugs globally. MAC's registered Qualified Persons (QP) are experienced in the global procurement, distribution, and supply of licensed and unlicensed medications. Importantly, MAC is highly experienced in the regulatory and ethical considerations for running psychedelic research.
Key elements of our operational strategy include
• For Early phase studies self-contained, isolated areas housed within an MHRA accredited unit. This enables MAC to deliver studies with hallucinogenic compounds ranging from first administration into man, through to proof of concept studies in vulnerable patients, which include sensitivities around addiction intervention studies.
• For Late phase studies fully staffed, self-contained, isolated areas housed within bespoke research centres. This enables MAC to deliver studies with hallucinogenic compounds to larger populations across a wider geographical area.
• MAC controls staff numbers who work on these studies and interact with participants. All staff from the receptionist through to patient facing investigators are trained in dealing with complex CNS studies, patient interactions and minimising placebo-effects.
• The environment within the dedicated area is conducive to experiencing a safe, relaxed hallucinogenic experience. To minimise Acute Psychological Distress rooms for experiencing a hallucinogenic episode are specifically designed and all staff who connect with the participant are trained to maintain this setting. During a session, mentors focus on psychologically supporting and ensuring data is collected to the highest standard.
• All work is carried out to the highest levels of GCP and quality.
• Options for continuously monitoring a participant may include ambulatory blood pressure, SpO2 and telemetry. A full array of sleep studies is available if required.
• During the course of a study trained psychiatrists and psychologists monitor for Prolonged Psychological Distress and are highly knowledgeable in local mental health care pathways.
• Our patient engagement team at MAC are highly experienced in recruiting patients with Depressed Mood, Anxiety Disorders, Obsessive-Compulsive Disorder (OCD), PTSD, Opioid Addiction, Alcohol Dependence, Smoking Cessation, Migraine e.g. Cluster Headaches and Treatment-Resistant Depression (TRD).