FDA Urges Effective Cocaine and Meth Addiction Treatments: Take Action Now!

The Food and Drug Administration (FDA) has released draft guidance aimed at advancing the development of treatments for substance use disorders associated with stimulants such as cocaine and methamphetamine.

The FDA’s draft guidance provides recommendations for the design of clinical trials for drugs intended to treat moderate to severe cocaine use disorder, methamphetamine use disorder, or prescription stimulant use disorder.

Given the lack of FDA-approved treatments for stimulant use disorder, the guidance acknowledges that there are uncertainties surrounding the optimal approach.

“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 urgently needed to address treatment gaps,” said Marta Sokolowska, deputy center director for Substance Use and Behavioral Health at the FDA.

“The guidance is part of the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants and the development of evidence-based treatments for stimulant use disorder,” Sokolowska added.

Among the recommendations, the FDA advises conducting separate studies with individuals who have different use disorders, meaning that people with cocaine, methamphetamine, and stimulant use disorders should be studied separately. The agency also suggests that the trials should be randomized, double-blind, and placebo-controlled, which is considered the “gold standard” for evidence collection.

In addition to historic urine toxicology testing in stimulant use disorder trials, the FDA suggests the use of other measurements. The agency explains that urine toxicology tests do not indicate how the subject feels, functions, or survives.

“Although we have previously suggested that a sustained period of negative urine toxicology findings, indicating abstinence, could serve as a valid measure of clinical benefit, the FDA does not advocate for urine toxicology results alone as the sole appropriate endpoint, based on the number of subjects achieving complete abstinence,” the agency acknowledged.

A public comment window is now open for this guidance, allowing individuals to submit comments until December 4th.

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