Gender issues and the pharmacotherapy of substance abuse

In the last 25 years, the different disciplines and professions that are involved in managing the issue of substance abuse have recognized that gender-linked factors influence patterns of substance abuse and response to treatment. In 2007, the US National Institute on Drug Abuse (NIDA) concluded that studies of substance abuse should routinely address gender issues. In the field of drug development, gender issues historically have not been an issue of high priority. By outlining the types of evidence that underpin the view of the NIDA and providing evidence of the widespread existence of gender-linked effects from pharmacotherapies (both those marketed and under development), this feature review proposes that drug developers should embrace the opinion of the NIDA regarding gender and substance abuse. To avoid false conclusions, the issue of gender should become a higher priority during the collection and analysis of data on pharmacotherapies. Some gender differences will have more clinical significance than others, but any difference related to gender has the potential to complicate clinical trials and other studies.