May 13, 2009
by Dr. Nora D. Volkow
In response to recent concerns raised in the media about administering abused drugs to human subjects who are addicted (VA Researchers Gave Morphine to Addicts in Study, 5/5/09), I invite you to consider the following.
The National Institute on Drug Abuse (NIDA) serves as the catalyst for advancing our understanding of addiction as a brain disease. Our ultimate goal is to help people recover from a disease that has devastating consequences for the individual, his/her family, and to society as a whole.
Essential to achieving this goal is clinical research wherein drugs of abuse, including opiates and stimulants, are administered to human subjects who abuse or are dependent on them. This is necessary, for example, in order to get a medication approved for treating drug addiction, including withdrawal symptoms and relapse prevention. Approval entails demonstrating both efficacy and safety, which includes evaluation of possible interactions with the abused drug. The only way to assess this is in drug-abusing populations under well-supervised conditions so that subjects can be properly monitored. And it is only through the arduous process of testing for safety and efficacy in relevant populations that new medications can become available for clinical use.
To ensure the proper balance of risks and benefits and informed consent, NIDA takes needed precautions for all the studies we support. All studies, including clinical studies that give morphine to heroin abusers in laboratory settings, must be fully justified by a thorough and rigorous assessment of scientific merit, investigator and institution qualifications, and adherence to ethical standards for conducting research in human subjects. This includes mandatory adherence to regulations governing use of human subjects in research in general and, when giving substances of abuse to substance abusers, specific ethical guidelines developed by NIDA’s National Advisory Council on Drug Abuse (NACDA) in 2000.
By participating in research that can lead to treatments for substance abuse, substance abusers can contribute to knowledge that could eventually directly benefit them. In addition, NIDA’s guidelines recommend that individuals participating in these research protocols be linked to substance abuse treatment programs. Moreover, studies that have followed substance abusers after participating in clinical studies that administered drugs of abuse in a laboratory setting have found no evidence of adverse health effects, with some demonstrating reduced use of the drug after participation.
NIDA is fully committed to ensuring that rigorous ethical and scientific standards are applied to the research it supports. It is also committed to bringing better treatments to the millions of individuals afflicted by drug addiction.
Nora D. Volkow, Director
National Institute on Drug Abuse
May 13, 2009