The U.S. Food and Drug Administration (FDA) provided draft guidance Wednesday for clinical trial design and the drug development process for drugmakers to produce treatments for stimulant use disorder, Axios reports. There aren't any approved treatments to help address addiction to cocaine, meth or prescription stimulants, whose use has surged in recent years, often in combination with opioids. The FDA noted there are opportunities for "more person-centered" trials with greater sensitivity to detecting a treatment's effect, while there are "a number of uncertainties" about the best approaches for treating stimulant use disorder or evaluating responses to treatments. The agency said there is such a wide range of symptoms that it could be difficult to identify which medications are effective for cocaine or meth — or stimulant use more broadly. Among other considerations, the agency recommended clinical trial sponsors separately study people who use cocaine, meth and prescription stimulants to improve the odds of developing successful treatments.
The agency said it's open to other measures of a treatment's effectiveness besides abstinence from drug use. For instance, measuring days of nonuse may reflect "meaningful improvement" and may be more practical than other ways of establishing benefit, the guidance says. It also said some treatments may be eligible for FDA's expedited approval pathways for addressing a major unmet medical need. The FDA "strongly" recommended that trial sponsors provide behavioral treatment to all trial participants. "When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps," said Marta Sokolowska of FDA's Center for Drug Evaluation and Research.