DO NOT ABBREVIATE it to University of Alaska
ANCHORAGE, ALASKA -- Dr. Alan Leshner, Director of the National Institute on Drug Abuse, has given final approval to University of Alaska Anchorage (UAA) Researcher Dr. Dennis G. Fisher to begin recruiting participants for a controversial $2.7 million dollar needle exchange clinical trial to reduce Hepatitis B incidence among injection drug users.
Originally awarded in September of 1996, the project has been on hold while bioethicists, federal scientists and politicians reviewed the "informed consent" aspect of the study. In November Dr. Harold Varmus, Director of the National Institutes of Health, commissioned a 10-member panel to review the human subject approval given by the UAA Institutional Review Board and federal Office of Protection from Research Risks. The advisory panel found no scientific or ethical flaw that would preclude funding the study but Dr. Varmus asked Dr. Leshner to award supplemental funds to provide vouchers for hepatitis B vaccination for those not eligible for Medicaid or Indian Health Service.
The three-year $2.7 million dollar study will compare the incidence of hepatitis B virus (HBV) between participants who obtain clean syringes through needle exchange programs to those who purchase them at pharmacies.
The following protocol changes will guide the conduct of the study:
Former injectors are to be excluded from the study design.
The research project will be expected to enroll at least 600 and up to 1,100 current injection drug users in this study with equal numbers of injectors assigned to each of the two intervention arms.
Working with the Alaska Pharmaceutical Association to ensure access to syringes for those intravenous drug users assigned to the enhanced pharmacy option, Dr. Fisher will also meet personally with pharmacists and pharmacy managers from each pharmacy during the first year of the study to explain the study and to reinforce their support.
All research participants will be offered the hepatitis B vaccine. Those individuals who are not eligible for obtaining the vaccine through Medicaid, the Indian Health, or private health insurance will be offered vouchers to cover the costs of the purchase of the cost of the hepatitis B vaccine.
The Data Safety and Monitoring Board will receive periodic data (particularly data about access to syringes from the pharmacies and incidence cases of HBV and HIV.)
Budgeted taxi services to transport participants from the field station will ensure access to receiving Health Department services (HBV vaccine, STD examination and treatment).
"This UAA study will not only demonstrate if needle exchange is effective in prevention of the spread of disease, but also if needle exchange itself encourages injection drug use, " said UAA Associate Vice Chancellor for Research and Graduate Studies Janett Trubatch.
The three-year project will study two groups of injection drug users in Anchorage, Dr. Fisher explains. One group will receive needles through legal pharmacy sales and the second group will receive needles through a needle exchange. All subjects will be followed and monitored every six months. A Data Safety and Monitoring Board will oversee the research progress and have oversight over the ethical issues involved in the research.
"Anchorage may be one of the only, if not the only, place in the world to carry out this kind of study," Fisher said. "Hopefully we can provide the clinical evidence so that the federal government can go ahead and make its decision about the use of needle exchange."
If it is determined that the needle exchange both reduces the spread of disease and does not encourage drug use, then this could be an impetus for states to eliminate laws prohibiting non-prescription needle dispensing, for development of state or local support of needle exchange, for the federal government to support needle exchanges across the country, or for the private sector to support needle exchange, Fisher added.
NIDA grant approval was based on a number of specific advantages to conducting this research in Anchorage, Fisher said. Among the advantages listed are: an ongoing injection drug user study, a low rate of HIV transmission (in case either the treatment or the control conditions do not effectively reduce risk behavior), a moderate rate in the incidence of Hepatitis B (to provide a viral measure of effectiveness), only one brand of syringe is normally found on the street and reported by injection drug users, no legal barrier to the establishment of needle exchange and a relatively closed population of intravenous drug users.
Dr. Fisher is Professor of Psychology in the College of Arts and Sciences at University of Alaska Anchorage. He has been involved in the field of drug abuse research since 1972.