ArticleDoes participation in an alcohol administration study increase risk for excessive drinking?
Introduction
In the past decade, alcohol research has made great strides in improving our understanding of the disease process involved in alcohol addiction. Through the study of the neurobiological and behavioral mechanisms underlying alcoholism, the field has generated a clearer picture of how the disease develops and persists. These advancements have been made in large part through animal and human laboratory research. In the case of human research, many studies have involved laboratory alcohol administration and self-administration.
The benefit of laboratory alcohol research with human subjects is clear. The discovery of new treatments for alcoholism translates into reduced medical costs, reduced societal costs, and reduced costs to individuals who suffer from alcoholism to the families of such individuals. There is also good scientific rationale for testing alcohol-dependent individuals in laboratory research. The data generated from studies testing alcoholics have much greater generalizability than data generated from social drinkers or even alcohol abusers. However, alcohol administration studies raise many ethical issues that have been debated in the literature, and the risk:benefit ratio for the individual study participant has not been systematically studied (see the discourse between Koocher, 1991 and Jacob & Leonard, 1991 for a discussion of these issues). Underlying many of these ethical concerns is the assumption that participating in an alcohol administration study contributes to or exacerbates hazardous drinking behavior and puts alcoholics in treatment at risk for relapse (see Wood & Sher, 2000 for a discussion of potential risks). While this concern has intuitive appeal, there is actually no scientific evidence to justify the concern (see Dolinsky & Babor, 1997). Interestingly, studies conducted in the 1970s demonstrated that alcohol-dependent subjects are capable of controlling their alcohol intake under certain situations (Marlatt et al., 1973, Mello and Mendelson, 1972). The findings from these early studies argue against the assumption that exposing alcoholics to alcohol automatically puts them at risk for relapse.
Recently, Drobes and Anton (2000) challenged the assumption that participating in an alcohol administration study promotes hazardous drinking. They conducted an ancillary analysis examining subjects' drinking behavior following their involvement in a study investigating the impact of opiate antagonist treatment on alcohol cue reactivity and self-administration. Non–treatment-seeking alcoholics attended two assessment sessions, followed by a week-long regimen on one of three medications (naltrexone, nalmefene, or placebo), a day-long laboratory assessment including a standardized alcohol administration procedure, and a debriefing session consisting of individualized feedback and alcohol counseling. Follow-up consisted of a telephone interview 6 weeks after the alcohol challenge session. At the follow-up interview, subjects reported significant reductions in drinking quantity and frequency compared with the prestudy period. Although two of the test groups were taking medications known to reduce alcohol consumption, none of the subjects in any of the three groups reported increased drinking following study participation. The authors concluded that alcohol administration research procedures may not be detrimental to the poststudy drinking behavior of alcoholics. They further proposed that the use of such procedures could be cautiously expanded to improve the generalizability of findings for alcoholic populations of interest.
While the results of previous studies suggest that participating in an alcohol administration study does not increase subsequent drinking, these studies included subjects who were treated with a pharmacotherapy for reducing alcohol intake. It is possible that changes in drinking behavior observed after involvement in those studies were influenced by the effects of the medications that were administered. Therefore, the present study builds upon previous studies by examining the association between participating in a laboratory alcohol self-administration study and the subsequent drinking behavior of non–treatment-seeking alcoholics and social drinkers who were not previously treated with a pharmacotherapy to reduce drinking.
Section snippets
Subjects
All recruitment, screening, and testing procedures used in this study adhered to the guidelines set forth by the National Advisory Council of the National Institute on Alcohol Abuse and Alcoholism for administering alcohol to humans (NAC, 1989), specifically those which address administering alcohol to alcoholics. All procedures were also approved by the Institutional Review Board at Indiana University and met requirements for informed consent, confidentiality, and full protection of the
Alcohol consumption
The mean PDA during the 6-week prestudy period compared with the 6-week poststudy period can be seen for both subject samples in Table 2. There was a statistically significant increase of 24.0% in PDA for the alcoholic sample poststudy (mean = 52.6%, S.E.M. = 6.1%) compared to PDA assessed prestudy (mean = 28.6%, S.E.M. = 3.8%) (t(26) = −4.07, P < .001). No significant difference in PDA was observed for social drinkers poststudy (mean = 69.5%, S.E.M. = 3.3%) compared to prestudy (mean = 68.8%, S.E.M. = 3.8%).
Discussion
The results of this study suggest that participation in a laboratory alcohol administration study does not appear to precipitate increased alcohol consumption in either social drinkers or non–treatment-seeking alcoholics (with the exception of a significant increase in PHDD for social drinkers, which is likely attributable to the fact that the follow-up period occurred over the winter holidays). This finding is of considerable importance for the field of alcohol research from an ethics
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Supported by NIH grant #P60 AA07611-19 Pilot Project 43.