Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

DESCRIPTION: The primary objective of this double-blind, placebo-controlled, adaptive, randomized clinical trial is to evaluate the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Secondary outcomes will assess the safety of naltrexone plus bupropion and determine the efficacy of the combination pharmacotherapy on other substance use outcomes, on depression symptom scores, and on quality of life ratings. 370 individuals with moderate or severe methamphetamine use disorder will be randomly…

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CBT4CBT FOR ALCOHOL OR OPIOID USE DISORDER

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. OUTCOMES: Though this study has completed enrollment, data analysis is still underway. Results will be posted here once available.

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Combating Craving with Contingency Management: Neuroplasticity and Methamphetamine Abuse in South Africa

RELEVANCE: Methamphetamine (MA) addiction is a global health problem with high prevalence and great social and health costs in the United States and in the Republic of South Africa and there is a strong need for development and implementation of effective MA treatment approaches. DESCRIPTION: This study will enroll treatment-seeking, MA-dependent individuals into an 8-week contingency management (CM) program. At the beginning and end of the program, participants will participate in MRI scans while performing…

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Contingency Management, Methamphetamine Use, and Antiretroviral Adherence for MSM (CMAX)

RELEVANCE: Use of crystal methamphetamine (MA) leads to changes in sexual risk behavior, adherence to biomedical prevention, viral immunology, and mucosal inflammation that increase risk for HIV-1 transmission among MA-using men who have sex with men (MSM), their sexual partners, and their networks. Contingency Management (CM) offers a behavioral modification tool efficacious for reducing frequency of MA use, but the effects of CM on the behavioral and biological factors that promote HIV transmission in MSM…

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Determining the Efficacy of Cognitive-Behavioral Motivational Enhancement +/- Nicotine Replacement Therapy for Adolescents

DESCRIPTION: In order to develop a tailored, practical, and efficacious smoking cessation intervention that starts with a behavioral platform and offers the potential for pharmacotherapy (in this instance, nicotine transdermal therapy using Nicoderm CQ®), 84 subjects ages 14-21 were recruited for this 24-week study. Participants reported smoking at least 5 cigarettes daily in the month before entry into the study and initiation of smoking at least 6 months before entry. All youth received 6 weeks…

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HIV/STD Risk Behaviors in Methamphetamine User Networks — Main Study

DESCRIPTION: Funded by the National Institute on Drug Abuse (U01 DA017394), this project was a part of the SATHCAP (Sexual Acquisition and Transmission of HIV Cooperative Agreement program). The primary purpose of the main study was to determine the extent to which HIV infections spread through drug-related and sexual transmission behaviors. We also sought to identify the individual, network, and structural characteristics that influence the speed, extent and path of transmission. Learn more about the…

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HPTN 073: PRE-EXPOSURE PROPHYLAXIS UPTAKE AND ADHERENCE AMONG BLACK MEN WHO HAVE SEX WITH MEN (BMSM)

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…

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HPTN 085: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection (AMP)

RELEVANCE: Preliminary data have shown antibodies to be a potential efficacious intervention in preventing HIV-1 infection. DESCRIPTION: This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in healthy adults at high risk of HIV infection. Participants will be men who have sex with men (MSM) and transgender people in the U.S., Peru and Brazil. An equal number of study participants will be randomized to receive VRC01 mAb…

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HPTN061: The BROTHERS Study (Broadening the Reach of Testing, Health Education, Resources and Services for Black Men Who Have Sex With Men)

DESCRIPTION: The BROTHERS study, a project of the HIV Prevention Trials Network (HPTN), aimed to see if certain strategies can show promise for slowing down the spread of HIV among Black men who have sex with men (Black MSM). Another aim is to better understand the men’s lives and how that relates to HIV risk. OUTCOMES: The overall rate of new HIV infection among Black MSM in this study was 2.8% per year, a rate that is nearly…

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HPV in MA Using and Non-Using MSM in LA — Supplemental Study

DESCRIPTION: This was a sub-study of the project “HIV/STD Risk Behaviors in Methamphetamine User Networks”. It sought measure the prevalence anal human papillomavirus (HPV) among HIV-negative MSM who use methamphetamine compared to those who do not use methamphetamine. OUTCOMES: The supplemental project extends the breadth of research findings in the main study by documenting that the primary drivers of high-risk anal HPV are linked to HIV-infection, MSMW behaviors, and being African American. Use of methamphetamine…

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HVTN 302: A phase 1, randomized, open-label clinical trial to evaluate the safety and immunogenicity of HIV trimer mRNA vaccines in healthy, HIV-uninfected adult participants.

RELEVANCE: Development of effective vaccines to protect individuals against HIV is a challenging and growing public health priority. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV globally. DESCRIPTION: The HVTN 302 study is a phase 1 clinical trial looking to evaluate the safety and immunogenicity (how the immune system responds)…

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Methamphetamine-Associated Factors in Recent and Chronic Infection in MSM in Los Angeles — Supplemental Study

DESCRIPTION: This was a sub-study of the project “HIV/STD Risk Behaviors in Methamphetamine User Networks”. The purpose of the project was to assess the characteristics of the HIV virus in methamphetamine-using MSM that may be associated with efficient transmission of new infections. These characteristics include viral load, genotype, extent of treatment. We also sought to evaluate the behavioral similarities between individuals with treatment-resistant strains of HIV such as their patterns of methamphetamine use, sexual practices,…

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Methods of Using Real-Time Social Media Technologies for Detection and Remote Monitoring of HIV Outcomes — Supplemental Study

DESCRIPTION: This study sought to establish methods of using real-time social networking data for HIV prevention by assessing 1) whether geolocated conversations about HIV risk behaviors can be extracted from social networking data, 2) the prevalence and content of these conversations, and 3) the feasibility of using HIV risk-related real-time social media conversations as a method to detect HIV outcomes. OUTCOMES: Over 9800 geolocated tweets were extracted and used to create a map displaying the…

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Moderna’s mRNA-1273 vaccine, The COVE Study

RELEVANCE: SARS-CoV-2 is the virus that causes the disease called COVID-19, short for “Coronavirus Disease of 2019”. Finding an effective vaccine for COVID-19 is one of several steps being taken to end this global pandemic. DESCRIPTION: The purpose of this study is to test Moderna’s vaccine candidate (mRNA-1273) to see if it can prevent illness if people are exposed to the SARS-CoV-2 virus in their everyday lives. This vaccine is not made from the SARS-CoV-2…

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Molecular Epidemiology of HIV in MA Using and Non-Using MSM, MSM/W and Their Partners in LA — Supplemental Study

DESCRIPTION: This was a sub-study of the project “HIV/STD Risk Behaviors in Methamphetamine User Networks”. The purpose this project was to investigate epidemiological clustering of HIV as revealed by viral phylogenetic analysis to support or refute epidemiological linkage of pairs of HIV infected individuals, to describe broad patterns of clustering of infections by ethnic group and by structural features, and to describe the epidemiology of drug resistant HIV within this population OUTCOMES: In our initial…

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Perceptions of Intentions to Adopt HIV Pre-exposure Prophylaxis Among Black Men Who Have Sex With Men in Los Angeles.

DESCRIPTION: This study assessed perceptions of pre-exposure prophylaxis (PrEP) and their association with PrEP adoption intention among a convenience sample of 224 low socioeconomic status Black men who have sex with men (BMSM) residing in Los Angeles. Participants received educational information about PrEP and completed an in-person interview. OUTCOMES: More than half of the participants indicated a high intention to adopt PrEP. BMSM (18-29 years) were twice as likely to report a high intention to…

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Pharmacogenomics and Anti-Addiction Medication Development

DESCRIPTION: Genetic differences are thought to be an important biological predictor of response to treatment for addiction. The purpose of this project was to identify genetic factors influencing addiction severity and response to anti-addiction medications, with an emphasis on medications to treat methamphetamine dependence. We collected DNA specimens from a sample of well-phenotyped methamphetamine users who were participating in our clinical studies, including a pharmacogenetic clinical trial of bupropion for methamphetamine dependence. This outpatient study…

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Phase 1 Safety-Interaction Study of Pomaglumetad Methionil For Methamphetamine Use Disorder

RELEVANCE: Despite multiple clinical trials testing medications targeting dopaminergic, serotonergic, cholinergic, and gaba-ergic systems, no effective medication for methamphetamine (MA) use disorder is currently available. DESCRIPTION: This is an inpatient, phase I safety-interaction trial of POMA (Pomaglumetad Methionil) in participants with MA (methamphetamine) use disorder. The goal of the study is to provide the initial safety, tolerability, and pharmacokinetic (PK) data required by the FDA to advance POMA to phase 2 safety and efficacy testing.…

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Phase I Safety Interaction Trial of Ibudilast with Methamphetamine

DESCRIPTION: To date, no medications have been approved expressly for the treatment of methamphetamine dependence, leaving few options for doctors and patients battling this particular addiction. This clinical trial sought to determine the safety and tolerability of the medication ibudilast in non-treatment seeking, methamphetamine-dependent volunteers.The study took place at the Harbor-UCLA Medical Center in Torrance. Preliminary outcomes of the trial were presented at the 2013 College of Problems on Drug Dependence Conference in San Diego.…

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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…

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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…

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Pilot Randomized Trial of Bupropion for Adolescent Methamphetamine Abuse/Dependence

DESCRIPTION: The purpose of this pilot clinical trial was to determine the safety of bupropion for methamphetamine abuse/dependence among adolescents. Nineteen adolescents were randomly assigned to bupropion sustained release 150mg twice daily or placebo for 8 weeks in addition to outpatient substance abuse counseling. OUTCOMES: Bupropion was well-tolerated except for one female in the bupropion group who was hospitalized for suicidal ideation during a methamphetamine relapse. Those participants who received bupropion and females in the…

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Randomized, Placebo-Controlled Trial of Bupropion for the Treatment of Methamphetamine Dependence

Randomized, placebo-controlled trial of bupropion for the treatment of methamphetamine dependence DESCRIPTION: This study sought to compare bupropion to placebo for reducing methamphetamine (MA) use, increasing retention, and reducing the severity of depressive symptoms and MA-cravings. Additionally, a secondary objective compared bupropion to placebo for reducing cigarette smoking among MA dependent participants. Following a 2-week, non-medication baseline screening period, 73 treatment-seeking MA dependent participants were randomly assigned to bupropion sustained release (150 mg twice daily;…

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Technology Improving Success of Medication-Assisted Treatment in Primary Care

RELEVANCE: The opioid epidemic is U.S.’s most widespread behavioral public health problem, with a higher number of deaths due to overdose in 2016 compared to deaths due to HIV at the peak of the AIDS epidemic. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious. However, only a fraction of persons with OUD access MAT and treatment non-adherence and drop out is common. There is a dire need to improve systems to…

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The LA PrEP Stories Project

RELEVANCE: Pre-Exposure Prophylaxis (PrEP) has the potential to reduce the number of new HIV infections among high-risk black and Latino men who have sex with men (BLMSM). However, issues related to the adoption of PrEP may negatively influence PrEP disclosure, diffusion, adherence and retention among BLMSM who adopt PrEP. The findings from this study will inform the development of intervention activities that seeks to prevent or moderate the negative social experiences associated with PrEP adoption…

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Varenicline for Methamphetamine 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. OUTCOMES: Varenicline was well tolerated, but was not found to be universally efficacious for achieving MA abstinence in this Phase 2 clinical trial. 1. Briones M, Worley…

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