Guest Editorial – Advancing Reduction of Drug Use as an Endpoint in Addiction Treatment Trials (Nora D. Volkow, Director, National Institute on Drug Abuse)
Guest Editorial – Advancing Reduction of Drug Use as an Endpoint in Addiction Treatment Trials (Nora D. Volkow, Director, National Institute on Drug Abuse)
For many people trying to recover from a substance use disorder, perhaps for the majority, abstinence may be the most appropriate treatment objective. But complete abstinence is sometimes not achievable, even in the long-term, and there is a need for new treatment approaches that recognize the clinical value of reduced use.
According to a recently published analysis of data from the 2022 National Survey on Drug Use and Health, two thirds (65.2 percent) of adults in self-identified recovery used alcohol or other drugs in the past month (1). There is increasing scientific evidence to support the clinical benefits of reduced substance use and its viability as a path to recovery for some patients. Reducing drug use has clear public health benefits, including reducing overdoses, reducing infectious disease transmission, and reducing automobile accidents and emergency department visits, not to mention potentially reducing adverse health effects such as cancer and other diseases associated with tobacco or alcohol.
The FDA has historically favored abstinence as the endpoint in trials to develop medications for substance use disorders. Abstinence has been evaluated using absence of positive urine drug tests, absence of self-reported drug use, and regularly attending sessions where drug use is assessed. But abstinence is a high bar comparable to requiring that an antidepressant produce complete remission of depression or that an analgesic completely eliminate pain. Recognizing this limitation, the FDA encourages developers of opioid (2) and stimulant (3) use disorder medications to discuss with the FDA alternative approaches to measure changes in drug use patterns. (ASAM weekly, 18.03.2025)