COM 0193.044 2006-2008 - Laserfiche WebLink

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This will be a double blinded study. Our proposed study in turn will provide nursing students and/or post graduate students with valuable research experience and seed further studies and grants. We will negotiate with existing residential amphetamine recovery treatment programs and Public Safety (prison/jail) personnel to incorporate our study as an added value to their existing programs. We will consider using subjects on all islands. This will involve the project in travel to and from the various facilities. Paradise Newland will help in negotiation and coordination and act as liaison with the various agencies and staff that are involved. Her diplomatic and language skills will improve communication throughout the project. We will be reporting our progress to Governor Lingle and Lt. Governor Aiona. Since the standard "Drug Court" assignment to residential amphetamine recovery treatment programs extends to two years, we will use atwo-year study period. These programs as well as the prisons/jails have medication distribution systems in place for distribution of methadone and other routine medications. We will utilize the existing medication distribution system to distribute the dextromethorphan and "nutriceuticals," and placebos. Therefore, the administration of the DM and nutrients should be a straightforward addition to existing programs. We expect that the subjects will be in a "Nare-Anon"-like program in addition to our interventions. We feel that this is fine, and that our protocol will only add to other positive pre-existing programs. Prisoners entering the system through "Drug Court" and other paths will be evaluated for use in the study. We will develop informed consent documents and videos describing the study and these will be shown to prospective subjects so that they can make an informed choice in language appropriate to their level of understanding and culture. The choice to be in the study will comply with the National Commission on Correctional Health Care standards and comply with other human subject review board requirements. Entry into the study will comply with all laws regarding prison/detention subjects. We will use standard psychological evaluation tools and existing toxicological (drug use/relapse) testing to determine use patterns, degrees of craving, and monitor the mood and state of the study subjects. During the study, degrees of craving will be assessed weekly. Data collectors and those administering assessment tools will be "blinded" to the subject's use of DM and nutriceuticals. The subjects will likewise be "blinded" to their category. This will be a "double-blind," placebo controlled, "cross-over" study. Therefore we can use "factor analysis" to determine the effects of DM and the nutriceuticals both individually and in combination. Since full withdrawal and readjustment of nerve receptor numbers can take several months, we will administer the DM and Nutrients on a daily basis for at least the first 6 months. We feel this should allow sufficient time for rebalancing the subject's biochemistry. It is suggested that the long acting Corm of DM up to 50 mg be administered two times per day. Following the first six months of the program, we may be able to reduce the amounts of DM. The amounts given will be evaluated and determined in part through the psychological assessments of cravings and sustained sobriety in the subjects. 3