4 Ways to Mitigate Challenges Associated with Clinical Studies Using Schedule I Therapeutics

When performing a clinical trial with a Schedule I, or Class I therapeutic, there are many aspects of the process to consider. Because these therapeutics require rigorous testing, your organization must ensure it is partnering with a CRO/CDMO that has the correct licenses in place, established shipping processes, customized testing sites, experienced scientific and technical staff, and much more. There has been an increase in CNS clinical trials focused on psychedelics, hallucinogens, and entactogens which have demonstrated potential therapeutic effects and deserve further research. If your organization intends to study Schedule I therapeutics in a preclinical, clinical, manufacturing or bioanalytical setting, you should be aware of the following potential challenges and considerations.

DEA License for the Testing Site

Before early clinical development can even begin, the CRO you partner with should have appropriate licenses from the Drug Enforcement Agency. The proper license is required to legally ship, handle, store, and work with controlled substances. First, the clinical trial sponsor is responsible for obtaining the license for storing and the active pharmaceutical ingredient (API). Once the API is shipped, the testing site must obtain site authorization to receive it, which includes demonstrating appropriate security and controls for the API. All products received by the testing site must be accounted for. Local laws must also be considered as they may affect your study’s timeline, transport, and the site’s ability to move from one stage of the project to the next.

Clinical Safety Concerns

Participants must be closely monitored during the trial of a Schedule I drug. Depending on the drug you are studying, cardiovascular and psychiatric side effects may present, including tachycardia, respiratory depression, psychosis, sedation, and functional or cognitive impairment. Drug-related mood changes should also be monitored, such as aggression or confusion. Seratonergic toxicity, or serotonin syndrome, is another important consideration.

Recruiting Inclusion and Exclusion Criteria

When you move to first-in-human clinical trials with healthy participants, you may consider a population with prior psychedelic experience. A central aspect of therapeutic studies is informed consent, which must prepare participants for any potential perceptual changes and other risks. Inclusion and exclusion criteria should cover current, past, and family history within two degrees. It should also include DSM-IV criteria for schizophrenia and other psychotic disorders, like bipolar I or II disorder; elevations in blood pressure; use of dietary supplements; and use of concomitant medication.

The Clinical Trial Setting

The Phase 1 clinical trial units where the study is conducted should be equipped to handle the investigational substance’s subjective experience and other effects. Staff should be highly experienced in administering different types of CNS-active drugs. They should also be well trained on the specific attributes of the investigational substance. The environment should be safe and comfortable, and safety should always be top priority. For example, EEG and telemetry equipment should be on hand to monitor vital signs, while crash carts with antipsychotic and anti-anxiety treatments should also be readily available. Beds should be at ground level, and there should be areas for desensitization and privacy with eyeshades, headphones, and screens for participant use in case of an adverse experience.

About Altasciences

As a mid-size CRO/CDMO, Altasciences offers pharmaceutical and biotechnology companies a proven, flexible, full-service approach to preclinical and clinical pharmacology studies. These studies include program management, medical writing, biostatistics, clinical monitoring, data management, formulation, manufacturing, and analytical services, all customizable to specific sponsor requirements. Altasciences has been partnering with sponsors for more than 25 years to help partners make educated, faster, and more complete early drug development decisions. Altasciences provides access to essential resources for early clinical development, including strategically located Phase 1 clinical trial units, access to over 580 beds across the U.S. and Canada, and over 1,000 trained staff members. Altasciences’s expertise covers a wide range of therapeutic areas, and the CRO is recognized as a leader in the field of CNS clinical trials.

Partner with Altasciences for help with your CNS clinical trials at https://www.altasciences.com/