Naltrexone in Clinical Practice — Some Lessons from the Phase II Experience as Related to the Proposed Phase III Work

Autor: H. Alex Bradford, Walter Ling, Neil B. Haas
Rok vydání: 1981
Předmět:
Zdroj: Drug Dependence and Alcoholism ISBN: 9781468436167
DOI: 10.1007/978-1-4684-3614-3_116
Popis: On the eve of Phase III naltrexone investigation, it seems appropriate to recall that it was almost excatly three and one-half years ago when the first naltrexone investigators’ conference was convened in this very city. We were preparing to launch the Phase II study and there was great excitement and considerable anxiety as we gathered to hear Drs. Martin, Resnick and others relate their early experience with narcotic antagonists. The questions then were whether a naltrexone study was clinically feasible, whether it would prove safe, whether it would be acceptable, and whether we could arrive at some preliminary indication of its clinical efficacy. Summarized in the preceding report were the results of a concerted effort in the intervening three years by many investigators and others associated with these projects. We have answered some of the questions and raised new ones. It seems apropos to review this experience as we prepare for the next steps in the clinical development of naltrexone.
Databáze: OpenAIRE