Ethical Considerations for Administering Alcohol or Alcohol Cues to Treatment‐Seeking Alcoholics in a Research Setting: Can the Benefits to Society Outweigh the Risks to the Individual?

Abstract

There has recently been a welcome surge of interest in the development of medications to augment psychosocial behavioral therapies to treat alcoholics. Preclinical studies are identifying candidate medications that may block reinstatement of alcohol-seeking behavior, a model of relapse in humans. The development of effective therapeutic agents can be speeded up by the establishment of research paradigms such as craving reduction, by which novel drugs can be initially evaluated with higher throughput and lower cost than a full clinical trial. If medications that facilitate abstinence are to be developed they may need to be tested in the target population—treatment-seeking alcoholics—rather than in heavy drinkers or non-treatment-seeking alcoholics. Thus to test whether a new medication is able to reduce or abolish craving for alcohol it may be necessary to administer alcohol or alcohol cues to treatment seeking, abstinent alcoholics in a research setting. The alcohol exposure could take the form of inhalation of alcohol fumes (George et al., 2008), tasting alcoholic beverages, drinking alcoholic beverages, or receiving alcohol intravenously either passively (alcohol-clamp method; Ramchandani and O’Connor, 2006) or actively (CASE method; Zimmermann et al., 2008). Some of the research designed to identify treatments may also involve the administration of drugs that may mimic the actions of alcohol, for example as shown in drug discrimination studies. Administration of these alcohol-like drugs may entail some of the same risks as administration of alcohol. The purpose of this commentary, distilled from ideas put forth at a roundtable at the 2008 RSA Annual Meeting, is to discuss whether the administration of alcohol to treatment-seeking alcoholics is ever justified. Can it ever be ethical to induce craving or give alcohol to treatment seeking, abstinent alcoholics? Can the benefits to society outweigh the risks to the individual? Can these risks be reduced to acceptable levels? What safeguards are currently in place and what research is currently being done in this domain? Can this whole issue be avoided by conducting research on alcoholics who choose harm reduction (reduced alcohol consumption) rather than abstinence as a treatment goal? The issue of administering alcohol to treatment-seeking alcoholics has been raised periodically (Dolinsky and Babor, 1997; Modell et al., 1993) and indeed there are national guidelines. This commentary will examine the issues described above in the context of the National Advisory Guidelines. In this commentary “alcoholics” refers to all individuals with alcohol dependence (American Psychiatric Association, 1994).