Phase II Randomized, Double-Blind Controlled Trial of HORIZANT® for Alcohol Use Disorder
RELEVANCE: Alcohol Use Disorder (AUD) affects 18 million Americans, and is linked to 80,000 deaths a year, presenting a staggering $224 billion dollar economic loss to society. Yet, there are only four medications approved by the FDA to treat AUD.
DESCRIPTION: The primary objective of this study is to compare the efficacy of HORIZANT® with a placebo on individuals with AUD. The secondary objectives are to assess other treatment benefits such as reduction in alcohol consumption, reduction in cravings of alcohol, mood, sleep quality, smoking quantity and frequency, and safety.
STATUS: Currently enrolling. For information, call us at 310-206-6756 or visit SurveyMonkey.
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.
CBT4CBT for Alcohol or Opioid Use Disorders
RELEVANCE: Substance use disorders are a significant public health concern causing devastating personal and public health consequences. The availability of FDA-approved medications for alcohol and opioid use disorders has created the potential to expand access to substance abuse treatment outside of the specialty sector into office-based and primary care settings. Insuring access to quality CBT services for patients receiving office-based treatment for opioid or alcohol use disorders is very important.
DESCRIPTION: CBT4CBT (computer-based training for cognitive-behavioral therapy) is a seven-module computerized training in cognitive behavioral therapy. The proposed pilot study will examine the feasibility and acceptability of CBT4CBT in office-based medication treatment of opioid and alcohol use disorders.
STATUS: Currently enrolling persons receiving medication treatment for alcohol or opioid use disorders. For more information, call us at 310-562-8746.
Adapting the HOPE social media intervention to reduce prescription drug abuse
Relevance: Prescription drug abuse has reached epidemic proportions in recent years, surpassing road traffic accidents to become the top cause of injury-related death in the United States. Chronic opioid therapy, prescribed to treat patients experiencing chronic pain, is the most frequently abused of all prescription medications. Complications from chronic opioid misuse/abuse include respiratory suppression, infectious disease transmission, drug dependence/addiction, and fatal overdose.
DESCRIPTION: Qualitative interviews to explore how the HOPE social media-based intervention can be adapted for opioid abuse/overdose prevention among patients on chronic opioid therapy.
STATUS: Currently enrolling (UCLA patients only).
Using Social Media with Latino Men Who Have Sex with Men for HIV Testing and Linkage
RELEVANCE: In Los Angeles County Latinos comprise approximately 50% of all annually reported HIV infections, and Latino men who have sex with men (MSM) make up 85% of all HIV infections among Latinos. Identifying innovative ways of engaging Latino MSM in HIV testing, medical care, and prevention services has the potential to decrease HIV transmission among this population and improve health outcomes of those living with HIV.
DESCRIPTION: We propose to develop a culturally-tailored intervention to increase HIV testing and linkage to HIV medical care and prevention services among Latino MSM unaware of their HIV status. The intervention will consist of three interconnected and complementary components: 1) the use of social media, 2) the use of conditional cash transfers, and 3) linkage coordination to HIV medical care and/or prevention services. Social networking sites (SNS) with geo-based location services will be used to recruit high-risk Latino MSM. We hypothesize that our culturally-tailored social media program will result in identifying higher rates of HIV-positive Latino MSM, newly-identified HIV-positive Latino MSM accessing HIV medical care, and HIV-positive and high-risk HIV-negative Latino MSM accessing HIV prevention services compared to the local standard of care.
STATUS: This study has completed enrollment and data analysis is underway. For information on the results of this study, please contact the Principal Investigator, Dr. Ron Brooks, at email@example.com or by phone at 310-794-0619 ext. 226.
MSM and Substances Cohort at UCLA Linking Infections Noting Effects (MASCULINE), better known as the M Study
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.
STATUS: Currently undergoing data analysis.