Advertisement

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

  • Walter Ling
  • Neil B. Haas
  • H. Alex Bradford

Abstract

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.

Keywords

Methadone Maintenance Opiate Dependence Narcotic Antagonist Naltrexone Treatment Great Excitement 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Bradford, A. and Kaim, S. 1977. Final Report: Double-Blind Place-bo-Controlled Study, Administered by the National Academy of Sciences to Evaluate the Safety and Efficacy of the Narcotic Antagonist, Naltrexone. Submitted to National Institute on Drug Abuse. March 30, 1977.Google Scholar
  2. Bradford, A. and Kaim, S. 1977. Final Report: National Institute on Drug Abuse Studies Evaluating the Safety of the Narcotic Antagonist, Naltrexone. Submitted to National Institute on Drug Abuse. May 26, 1977.Google Scholar
  3. Meyer, R.E. et al. 1976. Heroin Self-Administration: The Effects of prior Experience, Environment and Narcotic Blockade. Proceedings, 38th Annual Scientific Meeting, Committee on Problems of Drug Dependence. Nat. Acad. Sciences: 272–295.Google Scholar
  4. National Research Council Committee on Clinical Evaluation of Nar-cotic Antagonists. 1978. Clinical Evaluation of Naltrexone Treatment of Opiate-Dependent Individuals. Arch. Gen. Psychiatry. 35: 335–340.Google Scholar
  5. Resnick, R.B. and Washton, A.M. 1978. Clinical Outcome with Naltrexone: Prediction Variables and Follow-up Status in Detoxified Heroin Addicts. Annals of the N.Y. Acad. of Sciences. In press.Google Scholar
  6. Resnick, R., Fink, M., and Freedman, A.M. 1970. A Cyclazocine Typology in Opiate Dependence. Am. J. Psychiatry. 126: 1256–1260.Google Scholar

Copyright information

© Plenum Press, New York 1981

Authors and Affiliations

  • Walter Ling
    • 1
  • Neil B. Haas
    • 1
  • H. Alex Bradford
    • 2
  1. 1.Veterans Administration HospitalSepulvedaUSA
  2. 2.Biometrics Research InstituteUSA

Personalised recommendations