NIDA director: Rethinking SUD treatment goals

National Institute on Drug Abuse (NIDA) Director Nora Volkow wrote a blog on the need for new SUD treatment approaches that recognize the clinical value of reduced use.

• In trials to develop medications for substance use disorder, the Food and Drug Administration (FDA) has historically favored abstinence as the endpoint/goal, rather than reduced use.

The details: A model for evaluating treatments based on reduced use instead of abstinence exists with alcohol use disorder (AUD) and is in the works for smoking.

• The percentage of participants with no heavy drinking days is accepted by FDA as a valid outcome measure in trials of medications for AUD. The National Institutes of Health and FDA have recently called for consideration of study endpoints in addition to abstinence in research for new smoking cessation products.
• Reduction in alcohol or tobacco use is easy to measure since alcoholic beverages/tobacco products tend to be purchased and consumed in standard quantities. Substantial evidence supports the clinical benefit of reduction in heavy drinking days.

But:

• Objective assessment of use reduction for illicit substances presents greater difficulty given variability and uncertainty of the composition and purity of illicit drugs.
• Little research has been conducted on alternative endpoints in OUD treatment.

Why it’s important:

• Reducing drug use has clear public health benefits, including reducing overdoses, infectious disease transmission, car accidents, and emergency department visits, as well as reducing adverse effects such as cancer and other diseases associated with tobacco or alcohol.
• Broadening the goals of treatment could potentially expand treatment options, increase the number of people in treatment, and reduce stigma associated with return to use. Expecting complete abstinence may be unrealistic in some cases and can pose a barrier to treatment.