@article{498d41786a8d44f797543be5e7b9b336,
title = "The clinical usefulness off IMarcotic antagonists: Implications of behavioral Research",
author = "Meyer, {Roger E.} and Mirin, {Steven M.} and Altman, {Jack L.}",
note = "Funding Information: This research was supported by MINH Grant #5 PO1 00257: Harvard-Boston University Center for Biobehavioral Studies in the Addictions; NIMH Contract #HSM 42-72-208: A Research Paradigm for the Study of Opiate Antagonists, McLean Hospital, Belmont, Massachusetts (Expired December 3 1, 1974); and SAODAP Grant #DA 4 RG 01 0: Behavioral Pharmacology of Agonist and Antagonist Drugs, McLean Hospital, Belmont, Massachusetts. Funding Information: 10-page brochure which is given to each patient prior to admission. In addition, prospective subjects are taken on a tour of the research facility and hospital and given the opportunity to talk with former patients before agreeing to participate. On the day of admission, each subject is interviewed by an attorney who is the hospital civil rights officer and a member of the hospital Human Studies Committee. He alone obtains the patient{\textquoteright}s signature on the informed consent form but only after satisfying himself that the subject is well-informed and understands fully the nature of the project. In addition to the McLean Hospital Human Studies Committee, the project has also been reviewed by representatives from the Governor{\textquoteright}s Drug Abuse Prevention Council of Massachusetts and staff persons from the State Departments of Public Health and Mental Health. Visibility in the local community has also been enhanced by lengthy descriptions of the project in the Boston Globe. At the federal level, the project has been reviewed initially for an Investigational New Drug license by the Food and Drug Administration (FDA) and then again by the Joint FDA-National Institute on Drug Abuse Committee concerned with the distribution of Schedule One substances (heroin) to research investigators. The research protocol was also reviewed for grant support by two different committees of the National Institute of Mental Health (on two separate occasions) and by an Ad Hoc Committee reviewing clinical research center grants through the Special Action Office for Drug Abuse Prevention. Finally, the project also obtained approval under the authority of the Drug Enforcement Administration of the Justice Department. Table 1 describes the three research designs employed by us over the last eighteen months. Design 1 was employed in studies 1 through 4, Design 2 in the fifth study, and the final design in our more recent work. Regardless of design, the total daily dose of intravenous heroin available under blocked and unblocked conditions was identical and limited by the number of days of prior use (to accommodate tolerance), and the time elapsed since the last dose (to control accumulation). Heroin was available any time, day or night, but no more often than every 2 hr. The permissible 2-hr dose ranged from 0.5 mg on Day 1 to 5 mg on Day 10. By waiting 4 hr a subject could take twice the 2-hr dose and by waiting 6 hr he could triple the 2-hr dose. Waiting longer than 6 hr resulted in no",
year = "1975",
doi = "10.3109/00952997509005666",
language = "English (US)",
volume = "2",
pages = "417--432",
journal = "American Journal of Drug and Alcohol Abuse",
issn = "0095-2990",
publisher = "Informa Healthcare",
number = "3-4",
}
