The Food and Drug Administration (FDA) has issued a draft of new advice to assist with developing treatments for substance abuse disorders.
Recommendations on how to design clinical tests for medications that treat moderate to severe cases of cocaine use disorder, methamphetamine use disorder, or prescription stimulant use disorder are included in the draft guidance document.
At this time, there is no treatment for stimulant use disorder that the FDA has approved. The guidance recognizes a lack of clarity regarding the recommendations of the optimal strategy.
According to Marta Sokolowska, the deputy center director for Substance Use and Behavioral Health at the FDA, When the advice is finalized, they hope it will inspire the development of innovative therapies vitally required to address treatment gaps.
Other initiatives within the framework include the creation of evidence-based therapies for amphetamine use disorder and the appropriate prescribing of prescription stimulants.
The FDA advised doing research with people who had unique use disorders, such as cocaine, methamphetamine, and stimulant use disorders, so that each disorder may be investigated separately. In addition, the FDA suggested that the tests be conducted in a randomized, double-blind, and placebo-controlled manner, which is generally acknowledged to be the most reliable method for amassing evidence.
Even though urine toxicological testing has traditionally been utilized in clinical trials for stimulant use disorder to evaluate participants’ responses to therapy, the FDA recommended that other metrics be included. According to the FDA, urine toxicology tests do not provide information regarding the subject’s feelings, functioning, or survival ability.
The regulatory body admitted that in the past, they had suggested that a prolonged duration of negative urine toxicological tests, which indicates abstinence, could be a reliable proxy for clinical benefit. However, the FDA does not advise that the number of participants attaining total abstinence is the only relevant endpoint based on the findings of the urine toxicology test.
An opportunity for the public to provide feedback on this guideline is currently available; comments can be submitted until December 4th.