ELEVATED RATES OF EARLY DISCONTINUATION FROM PHARMACOTHERAPY TRIALS IN ALCOHOLICS AND DRUG-ABUSERS

The failure of subjects to complete clinical trials is a common proble m with important implications for the interpretation of study results, Although a substantial literature exists on the high prevalence of pr emature termination from psychiatric and substance abuse treatment set tings, there has been little attention paid to early discontinuation i n clinical trials, There is evidence that the presence of substance ab use predicts higher rates of early discontinuation. This, combined wit h a recent increase in efforts to develop medications for treatment of substance use disorders, led us to conduct a literature review to det ermine whether pharmacotherapeutic trials for patients with these diso rders have higher rates of premature discontinuation than comparable s tudies of patients with other psychiatric disorders, Of 267 articles t hat wore initially identified, 83 met predetermined criteria for inclu sion in the analysis. As hypothesized, after controlling for a number of potential contributing variables, treatment trials with substance a buse patients showed a significantly poorer retention rate than those of patients with other psychiatric diagnoses. The difference in retent ion rate was also evident when studies specific to alcohol dependence, the largest subgroup of substance use disorders, were evaluated separ ately. Although the retrospective nature of the study design limits th e conclusions that can be drawn, the results suggest that, in pharmaco therapy trials with alcoholics or other substance abuse patients, part icular attention should be paid to enhancing treatment retention.