Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects

Abstract

Research involving the administration of ethanol to human subjects has been conducted with some regularity since the 1960s. The purpose of this paper is to provide a broader discussion of the ethical and clinical issues pertaining to the administration of ethanol to subjects with a history of alcohol dependence and to assess the potential benefits and risks of ethanol administration research. Three kinds of investigation are reviewed: (1) basic scientific research on alcohol dependence and related disabilities; (2) clinical research that involves ethanol administration as part of the treatment; and (3) studies that have evaluated the short- and long-term effects of ethanol administration on the health and wellbeing of alcoholic research participants. It is concluded that ethanol administration research has not only contributed to the fund of knowledge about basic mechanisms of alcohol dependence; it has also advanced the scientific understanding of treatment. Moreover there is no compelling evidence that participation in ethanol administration research per se has adverse effects on alcoholic research subjects. In the interests of developing a practical approach to the ethical dilemmas posed by ethanol administration research, an ethical review process is suggested that takes into account the principles of respect for people, beneficence, and justice by tailoring the risk/benefit analysis to four types of research subjects: alcoholics recruited directly from the community, subjects recruited from residential treatment settings, recovering alcoholics, and alcoholics in outpatient treatment.

Alcohol Use Following an Alcohol Challenge and a Brief Intervention among Alcohol‐Dependent Individuals

“…Findings from human laboratory studies involving the direct administration of alcohol have advanced our knowledge of alcoholism etiology 1,2 and treatment development. 3 Nonetheless, the field has been challenged to determine the balance between the risks and benefits posed by administering alcohol to alcohol-dependent participants.…”

“…4,5 However, studies to date have found no evidence of adverse consequences to alcohol-dependent individuals who participate in alcohol administration studies. 2,4 A few studies have tested whether direct alcohol administration poses a risk for alcohol-dependent individuals. Drobes and Anton 6 investigated the drinking patterns of 25 alcohol-dependent participants in their study of the effects of naltrexone on response to alcohol cues and alcohol administration.…”

“…[11][12][13][14] The objective of this study was to build upon prior findings and conduct an initial, open label, and uncontrolled pilot study of a single session of MI for non-treatment seeking alcohol-dependent participants of an alcohol administration challenge study. 15 Alcohol use and motivation for change were measured at three time points: (1) at the intake assessment, (2) post-participation in the alcohol challenge and immediately prior to participation in the MI session, and (3) 1 month after the MI session (ie, 1-month follow-up). Consistent with previous studies, 6,7 no significant changes in alcohol use from intake assessment to post-alcohol challenge were expected.…”

Conversation with Roger E. Meyer

“…In our heroin studies, there was no difference in outcome on naltrexone at follow-up in the community between subjects who had received naltrexone on the unit (blocking the effects of heroin) and those who experienced unblocked heroin during 10 days of access [7]. Subsequently, our studies in alcoholics given an alcohol challenge and followed-up in the community showed no effect on compliance with the medication disulfiram [8] or on treatment outcome [9], compared with subjects who had not participated in the research.…”

Neuroscience research on the addictions: A prospectus for future ethical and policy analysis

“…According to Cohen, it is only ethical to give drugs of dependence in experimental studies to abstinent addicts and possibly those who are in treatment. Even though research suggests that alcohol-and drug-dependent people who participate in research are helped rather than harmed (e.g., Dolinsky & Babor, 1997;Gorelick et al, 1999), we anticipate that ethics committees will not approve studies that administer drugs of dependence to abstinent addicts. If ethics review committees accept Cohen's argument, the outcome could be that no experimental research will be undertaken in which drug-dependent people receive their drug of dependence.…”