To aid in developing treatments for substance use disorders linked to stimulants like cocaine and methamphetamine, the Food and Drug Administration (FDA) has released draft advice.
The 2021 NSDUH Annual National Report states that 1.7%, or roughly 4.8 million persons, of those 12 and older in 2021 reported taking cocaine in the previous 12 months. With skyrocketing numbers, the nation must take the correct initiatives to help the country.
The FDA's recent draft outlines the organization's suggestions for designing clinical trials for medications that treat moderate to severe cocaine use disorder, methamphetamine use disorder, or prescription stimulant use disorder.
The guidance states that recommendations were based on "a number of uncertainties" as there is presently no FDA-approved treatment for stimulant use disorder, making it difficult to determine the best course of action.
"Currently, there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps. "- Marta Sokolowska, Deputy Center Director for Substance Use and Behavioral Health under the FDA
Performing research with participants with distinct use disorders, i.e., cocaine, methamphetamine, and stimulant users, was also advised and should be investigated individually.
The FDA also suggested that the trials follow the "gold standard" of evidence-gathering, which is randomized, double-masked, and placebo-controlled studies.
They recommended using other metrics besides urine toxicology testing, which has previously been utilized in stimulant use disorder trials to gauge how participants respond to therapy. According to the FDA, urine toxicology tests don't show "how the subject feels, functions, or survives."
The government acknowledged that a prolonged duration of negative urine toxicological results, suggesting abstinence, could be a legitimate proxy for clinical benefit.
The number of participants attaining complete abstinence is the sole relevant endpoint based on urine toxicological data, but the FDA does not and has not recommended this.
Meth vs. cocaine: What's the difference?
The methamphetamine molecule is distinct from cocaine in that it shares structural similarities with both cocaine and the neurotransmitter dopamine, which is a critical player in the reinforcement of rewarding behaviors.
Although these stimulants' behavioral and physiological effects are comparable, their fundamental processes differ significantly from one another.
Methamphetamine has a far more prolonged duration of action, and a higher percentage of the substance remains unmodified in the body than cocaine, which is swiftly eliminated from and almost entirely digested in the body.
As a result, methamphetamine stays in the brain longer, ultimately resulting in persistent stimulant effects.
- FDA. FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders.
- National Institute on Drug Use. How is methamphetamine different from other stimulants, such as cocaine?
- National Institute on Drug Use. What is the scope of cocaine use in the United States?