Phase II Randomized Trial of Ibudilast For Methamphetamine Dependence
RELEVANCE: Despite numerous clinical trials, no medication has been approved to treat methamphetamine (MA) dependence. As a result, novel approaches to medication development for MA dependence, including linked medication development, where work in early safety trials can be used to inform the importance of continued (or not) assessment of novel or combination pharmacotherapies, is needed.
DESCRIPTION: Following up on the Phase I safety trial, the objective of this study is to test the safety and potential efficacy of ibudilast to treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce methamphetamine use and increase treatment retention more than placebo among patients seeking treatment for methamphetamine dependence. As HIV infection is a common complication of methamphetamine dependence, half of the participants will be HIV positive and the study will assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4 count, risk behaviors).
STATUS: Currently enrolling treatment seeking, methamphetamine-dependent persons. For more information, call us toll free at 866-449-UCLA (8252) or email firstname.lastname@example.org.
Varenicline for Methamphetamine Dependence
RELEVANCE: Each year, 24.7 million people use amphetamine (MA) worldwide, which represents more consumers than individuals who use heroin or cocaine (United Nations of Office on Drugs and Crime, 2008). Despite the significant number of individuals impacted by MA use, there are currently no FDA-approved medications to treat MA dependence.
DESCRIPTION: The goal of this Phase II study is to test the early efficacy of the medication varenicline in treating methamphetamine dependence. The safety and tolerability of varenicline for the treatment of methamphetamine was tested previously and pilot data on the medication’s effectiveness was found to be promising.
STATUS: This study is no longer enrolling new patients.
HPTN 073: PreExposure Prophylaxis Uptake and Adherence among Black Men who have sex with men (BMSM)
RELEVANCE: Black men who have sex with men (BMSM) make up nearly 30% of all new HIV infections in the U.S. It is imperative that we explore prevention strategies that might help Black men to better protect themselves and their communities
DESCRIPTION: This is a collaborative project of the national HIV Prevention Trials Network (HPTN), protocol #073 (HPTN 073). The trial will test Truvada®, an HIV treatment medication, for pre-exposure prophylaxis (PrEP). PrEP is a new HIV prevention method in which people who are HIV-negative can be prescribed a daily HIV treatment drug to reduce their risk of becoming infected. The FDA approved Truvada® for use as PrEP in 2012. The Los Angeles site will enroll 75 BMSM over a one-year period.
STATUS: This study is no longer enrolling new patients.
MSM and Substances Cohort at UCLA Linking Infections Noting Effects (MASCULINE)
RELEVANCE: Stimulant use, especially among men who have sex with men (MSM) in Los Angeles County (LAC) is common. Stimulant drug use, particularly methamphetamine use, is a significant factor in the progression of HIV and STI among MSM in LAC. Non-white MSM are at greatest risk of HIV infection in the United States. Analyses of drug use are needed among diverse samples of MSM in order to understand the impact of drug use on the HIV epidemic over time and to address the effect of long-term drug use patterns on uptake and adherence to treatment and prevention of the disease.
DESCRIPTION: The goal of this project is to assemble a cohort of minority men who have sex with men (MMSM) who actively use substances and engage transmission risks. This will facilitate studies on interactions between substance use and HIV progression and/or transmission. This important cohort of MMSM will characterize: (i) effects substance use on risk behaviors, and network dynamics in exposed and infected MMSM on acquisition of HIV and other sexually transmitted infections (STIs: gonorrhea, Chlamydia, syphilis, Hepatitis C (HCV)); and (ii) the extent to which substance use in MMSM facilitates behaviors that transmit HIV compared to non-drug using MMSM.
STATUS: Currently enrolling at 2 sites. For more information, visit the study website at http://www.theMstudy.org.
Prototypical Identities of Young MSM: Typology and Social Context
RELEVANCE: Although men who have sex with men (MSM) continue to make up more than half of new cases of HIV in the U.S., new infections are increasingly among groups other than the traditional white, urban, gay-identified MSM. We know that MSM of color and younger MSM who do not identify with a gay community represent high-risk groups, are often less well informed about HIV and risk reduction strategies, and less likely to implement them (LACDPH HIV/AIDS Surveillance Summary, Malebranche 2008). There is a significant need for effective ways to reach these individuals to prevent HIV infection and dissemination.
DESCRIPTION:This study looks at how aspects of sexual identity mediate risk behaviors or accessibility to HIV-prevention intervention. It explores the self-concepts and behaviors of young adult MSM who do not identify as “gay,” combining ethnographic interviews and analysis of self-representations in internet and smartphone-based dating sites.
Potential Adoption of PREP Among Black/African American MSM in Los Angeles
RELEVANCE: According to the Centers for Disease Control & Prevention (CDC), black/African American men who have sex with men (MSM) have an increased chance of being exposed to HIV because of the larger number of MSM living with HIV. The CDC also notes that stigma, homophobia, and discrimination put MSM of all races and ethnicities at risk for multiple physical and mental health problems and affect whether MSM seek and obtain high-quality health services.
DESCRIPTION: The goal of this study was to assess the acceptability (i.e. adoption intentions) of Pre-Exposure Prophylaxis (PrEP) for HIV prevention among at risk black/African American MSM in Los Angeles County. The study also examined if social and behavioral factors such as HIV stigma, AIDS conspiracy theories, perceived risk of HIV, current HIV risk behaviors and access and use of health care services might facilitate or impede future adoption of PrEP among this population. The findings from this study will help inform the dissemination and optimal scale-up of this new biomedical HIV prevention strategy to at risk Black/African American MSM, a population that continues to be disproportionately impacted by HIV.
Though this study has completed enrollment, data analysis is still underway. To read a more in-depth abstract of this study, click here.