Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

BACKGROUND: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. METHODS: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. RESULTS AND CONCLUSIONS: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success.

Zinc status in human immunodeficiency virus type 1 infection and illicit drug use.

Zinc deficiency is the most prevalent micronutrient abnormality seen in human immunodeficiency virus (HIV) infection. Low levels of plasma zinc predict a 3-fold increase in HIV-related mortality, whereas normalization has been associated with significantly slower disease progression and a decrease in the rate of opportunistic infections. Studies in Miami, Florida, indicated that HIV-positive users of illicit drugs are at risk for developing zinc deficiency, at least partially because of their poor dietary intake. Zinc deficiency characterized by low plasma zinc levels over time enhances HIV-associated disease progression, and low dietary zinc intake is an independent predictor of mortality in HIV-infected drug users. The amount of zinc supplementation in HIV infection appears to be critical, because deficiency, as well as excessive dietary intake of zinc, has been linked with declining CD4 cell counts and reduced survival. More research is needed to determine the optimal zinc supplementation level in HIV-infected patients, to prevent further burden on an already compromised immune system.

Risk factors for HTLV-I mother to child transmission: influence of genetic markers

This study was designed to evaluate the influence of genetic markers on the seropositivity of offspring of HTLV-I positive mothers in Tumaco, Colombia, an endemic area for HTLV-I infection and a site where there exists a racially mixed population of Black and Caucasian ancestors. 33 HTLV-I seropositive women with at least one offspring were studied. A total of 111 offspring were tested using hemaglutination-inhibition for testing sera for the allotypic markers G1m (1,2,3, 17) and G3m (5, 6, 13, 21). Potential risk factors such as mother's age at child's birth, mother's age at the time of the study, breastfeeding months, TSP vs. asymptomatic HTLV-I carrier, sibship's size, children's age and sex, were not found to be associated with mother to child transmission. Mother's Negroid genetic marker genotype (1, 17, 5, 13/1, 17, 5, ñ 13) was margininally associated with mother to child transmission of HTLV-I (P=0.057; OR=11.97; CI=0.92-155.96).