Relevance: Phenotyping is a tool that has been recently introduced in the study of addiction and can be used to improve diagnosis and overall treatment outcomes. It aids in the identification of biological and behavioral markers of severity that can be useful in determining response to treatment. A recent study examined the feasibility and administration of the NIDA Phenotyping Assessment Battery (PhAB), a modular package of assessments and neurocognitive tasks, but the need for a large-scale phenotyping study to further explore the validity and utility of PhAB in clinical trials remains.

Description: This is a multisite observational study that involves administration of an assessment battery (including NIDA PhAB and SUDSS) to individuals meeting DSM-5 criteria for moderate or severe SUD seeking treatment or recently enrolled (within past 90 days) at up to five clinical sites. It aims to evaluate the feasibility, construct validity, and test-retest reliability of the NIDA PhAB and refine it into a very brief battery that can be efficiently embedded in future clinical trials, allowing for aggregation and comparison of data across studies, enhancing scientific yield and advancing personalized medicine for SUD.

Status: Currently enrolling. Please call 323-461-3106 for more information.

Relevance: Medication assisted treatment (MAT) is an essential part of evidence-based rapid response treatment and is highly effective in acute care settings. The California Bridge Program develops hospitals and emergency rooms as primary access points for addiction treatment. This intensive program provides training and technical assistance to acute care providers to encourage patients to enter and remain in treatment.

Description: UCLA CBAM is working in collaboration Public Health International (PHI) on a research study related to the Bridge Program that will (1) expand the assessment battery currently being used by PHI to make it comparable to other datasets currently being compiled in the setting of providing medication assisted therapy (MAT) in emergency care settings and (2) build a cohort of participants willing to be contacted for future research opportunities to test prospective hypotheses about long-term health outcomes when providing MAT in emergency health settings.

Status: This study is currently active.

Relevance: Determining whether a patient is both feeling better and improving physiologically when treating people living with HIV (PLWH) for methamphetamine use disorder (MUD) requires identification of a clinically significant measure separate from abstinence. This study aims to address this challenge by testing a gene expression pattern identified by the field of social genomics, which may provide insight into both psychosocial health and biological processes that impact chronic disease risk in PLWH receiving MUD treatment.

Description: The purpose of this study is examine methamphetamine treatment and its impact on immune function and mental health. It aims to investigate whether a neurally regulated “stress” gene expression pattern can serve as a clinically meaningful, non-abstinence-based endpoint for contingency management for methamphetamine (METH) use disorder (MUD) in MSM living with HIV.

Status: This study is currently active and enrolling participants at the UCLA Vine Street Clinic. Click here for more information.

HPTN 083: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis (PrEP) in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

Relevance: PrEP agents are needed that do not depend on daily or near-daily pill-taking. The development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents, could increase prevention choices and increase acceptability. Long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen.

Description: Once randomized to one of two arms, participants will move through the steps below and followed for up to 4 and a half years:

Step 1:
Arm A – Daily oral CAB (30 mg tablets) and oral TDF/FTC placebo for five weeks
Arm B – Daily oral TDF/FTC (300 mg/200 mg fixed-dose combination tablets) and oral CAB placebo for five weeks
A participant that becomes HIV-infected during Step 1 of the study will permanently discontinue study product and will be terminated from the study, and referred for HIV-related care.
Step 2:
Arm A – CAB LA (600 mg as a single intramuscular [IM] injection at two time points 4 weeks apart and every 8 weeks thereafter) and daily oral TDF/FTC placebo.
Arm B – Daily oral TDF/FTC (300/200 mg fixed-dose combination tablets) and IM placebo at two time points 4 weeks apart and every 8 weeks thereafter (matching vehicle, identical volume as active injectable product in Arm A).
This step will continue until the required number of endpoints is reached.

A participant that becomes HIV-infected during Step 2 of the study will permanently discontinue study product, be placed on immediate suppressive ART, and be followed for 52 weeks after their last injection, after which their participation in the study will end and they will be transitioned to continued HIV-related care.

Step 3:
Both arms: Open-label daily oral TDF/FTC no later than 8 weeks after the last injection (in order to cover the pharmacokinetic (PK) tail for Arm A participants), for up to 48 weeks.
Participants will then transition to locally-available HIV prevention services, including services for PrEP, if available.
A participant with confirmed HIV infection during Step 3 will be followed at least for the duration of Step 3.

Status: This study is still active, but is closed to new enrollments. Preliminary results can be reviewed at this link.

Relevance: Drug overdose is the leading cause of accidental death in the United States (US), with over 67,000 fatalities in 2018.1 Efforts to address the opioid overdose epidemic are reducing rates of death due to prescription opioids, though the rate of overdose related to fentanyl use continued to rise through 2018.1  The opioid epidemic remains North America’s most widespread behavioral public health problem, with a higher number of deaths due to drug overdose in 2016 compared to deaths due to HIV at the peak of the AIDS epidemic in the US.

Description: The purpose of this study is to determine the efficacy of using a mobile health delivery unit (“mobile unit”) to deliver “one stop” integrated health services – particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention – to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). The intervention arm receiving health services in the mobile unit will be supported by peer navigation. An active control arm will receive peer navigation to health services available at community-based agencies.

Status: This study is closed to enrollment and is currently completing the data collection phase. The first publication from the study is available here:

  1. Goodman-Meza D, Shoptaw S, Hanscom B, Smith LR, Andrew P, Kuo I, Lake JE, Metzger D, Morrison EAB, Cummings M, Fogel JM, Richardson P, Harris J, Heitner J, Stansfield S, El-Bassel N; HPTN 094 Study Team. Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study). Trials. 2024 Feb 15;25(1):124. doi: 10.1186/s13063-023-07899-5. PMID: 38360750; PMCID: PMC10870682. For more information, find the full-text article by clicking this link.

Relevance: Methamphetamine (MA) use is common among MSM and is an important driver of the HIV/STI epidemic. Understanding the biological and behavioral risk factors that drive ongoing HIV/STI transmission among MA-using MSM is critical to designing potent HIV prevention interventions. Prevalence of MA use is substantially higher among MSM (5.9% among HIV-negative MSM and 12.3% among MSM living with HIV) than the general population (0.7%) (2,3), with a 707% increase in MA-related mortality in Los Angeles County over the past decade. MA use is associated with increased risk for HIV/STI acquisition and impaired HIV virologic control. Lack of HIV virologic control among HIV-positive MA-using MSM, combined with increased HIV/STI prevalence within their sexual networks, contributes to ongoing HIV/STI transmission. As MA use is associated with high-risk behavior, it is important to study the impacts of MA use on the biological and behavioral factors that are driving HIV/STI transmission among MSM.

Description: This study will evaluate whether methamphetamine use and/or sexually transmitted infections influence levels of inflammatory markers (cytokines) in the blood and in the rectum. The study uses contingency management and will include visits three times a week over 8 weeks. Participants will also be asked to complete surveys, provide samples (blood samples and rectal swabs), and have urine tested for the presence of drugs. They will also be offered a prescription for HIV pre-exposure prophylaxis at enrollment.

Status: This study is currently active and enrolling participants at the UCLA Vine Street Clinic.

Click here for more information.

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: This study is now enrolling. For more information, visit the study website at http://www.theMStudy.org. While this study is on-going, several papers have been published using the findings to date. Several are included below for your reference:

  1. Blair CS, Needleman J, Javanbakht M, Comulada WS, Ragsdale A, Bolan R, Shoptaw S, Gorbach PM. Examining the Relative Contributions of Methamphetamine Use, Depression, and Sexual Risk Behavior on Rectal Gonorrhea/Chlamydia Among a Cohort of Men Who Have Sex With Men in Los Angeles, California. Sex Transm Dis. 2022 Mar 1;49(3):216-222. PMCID: PMC8821317.
  2. Blair CS, Javanbakht M, Comulada WS, Richter EI, Bolan R, Shoptaw S, Gorbach PM. Lubricants and rectal douching: associations with rectal gonorrhea, chlamydia, and/or syphilis infection among men who have sex with men. Int J STD AIDS. 2020 Oct;31(11):1040-1046. Epub 2020 Aug 4. PMCID: PMC7654094.
  3. Blair CS, Needleman J, Javanbakht M, Comulada WS, Ragsdale A, Bolan R, Shoptaw S, Gorbach PM. Risk Behaviors Associated with Patterns of Sexualized Stimulant and Alcohol Use among Men Who Have Sex with Men: a Latent Class Analysis. J Urban Health. 2022 Apr;99(2):293-304Epub 2022 Jan 14. PMCID: PMC9033896.
  4. Li MJ, Richter EI, Okafor CN, Kalmin MM, Dalvie S, Takada S, Gorbach PM, Shoptaw SJ, Cole SW. Social Genomics of Methamphetamine Use, HIV Viral Load, and Social Adversity. Ann Behav Med. 2022 Aug 30;56(9):900-908. PMCID: PMC9424866.
  5. Quinn B, Gorbach PM, Okafor CN, Heinzerling KG, Shoptaw S. Investigating possible syndemic relationships between structural and drug use factors, sexual HIV transmission and viral load among men of colour who have sex with men in Los Angeles County. Drug Alcohol Rev. 2020 Feb;39(2):116-127. PMCID: PMC8007134.
  6. Li MJ, Takada S, Okafor CN, Gorbach PM, Shoptaw SJ, Cole SW. Experienced homophobia and gene expression alterations in Black and Latino men who have sex with men in Los Angeles County. Brain Behav Immun. 2020 Jan;83:120-125. Epub 2019 Sep 26. PMCID: PMC6906252.
  7. Li MJ, Okafor CN, Gorbach PM, Shoptaw S. Intersecting burdens: Homophobic victimization, unstable housing, and methamphetamine use in a cohort of men of color who have sex with men. Drug Alcohol Depend. 2018 Nov 1;192:179-185. Epub 2018 Sep 13. PMCID: PMC6200602.
  8. Cohen JM, Li MJ, Javanbakht M, Gorbach PM, Shoptaw SJ. Methamphetamine use and adoption of preventive behaviors early in the COVID-19 pandemic among men who have sex with men in Los Angeles, California. Drug Alcohol Depend Rep. 2022 Dec;5:100097. Epub 2022 Sep 29. PMCID: PMC9519521.
  9. Shoptaw S, Li MJ, Javanbakht M, Ragsdale A, Goodman-Meza D, Gorbach PM. Frequency of reported methamphetamine use linked to prevalence of clinical conditions, sexual risk behaviors, and social adversity in diverse men who have sex with men in Los Angeles. Drug Alcohol Depend. 2022 Mar 1;232:109320. Epub 2022 Jan 19. PMCID: PMC8885921.
  10. Ciccarone D, Shoptaw S. Understanding Stimulant Use and Use Disorders in a New Era. Med Clin North Am. 2022 Jan;106(1):81-97. PMCID: PMC8670631.
  11. Okafor CN, Gorbach PM, Ragsdale A, Quinn B, Shoptaw S. Correlates of Preexposure Prophylaxis (PrEP) Use among Men Who Have Sex with Men (MSM) in Los Angeles, California. J Urban Health. 2017 Oct;94(5):710-715. PMCID: PMC5610125.
  12. Takada S, Gorbach P, Brookmeyer R, Shoptaw S. Associations of social capital resources and experiences of homophobia with HIV transmission risk behavior and HIV care continuum among men who have sex with men in Los Angeles. AIDS Care. 2021 May;33(5):663-674. Epub 2020 Oct 14. PMCID: PMC8044261.
  13. Gorbach PM, Javanbakht M, Ragsdale A, Bolan RB, Flynn R, Mandler R, Shoptaw S. Methamphetamine Injection Among Young Men Who Have Sex With Men: Risk for Human Immunodeficiency Virus Transmission in a Los Angeles Cohort. J Infect Dis. 2020 Sep 2;222(Suppl 5):S471-S476. PMCID: PMC7566619.

Relevance: Methamphetamine (MA) is more prevalent than many other drugs, including opioids, with 37 million users of MA and amphetamine worldwide and 1.4 million past-year users in the U.S. alone in 2016. The number of MA poisoning deaths has steadily risen in recent years, from >3,700 in 2014 to 10,333 in 2017. Importantly, MA has been recognized as contributing substantially to the U.S. opioid crisis, with about half of MA poisoning deaths also caused by opioids. In the U.S., the annual economic cost of MA use is estimated to be $23.4 billion and use is strongly associated with HIV transmission. There are no FDA-approved pharmacologic treatments for MA use disorder, a major gap in addiction medicine, especially because behavioral interventions alone have limited efficacy and would likely benefit from adjunctive pharmacologic therapy.

Description: Previous randomized, placebo-controlled, double-blind trials have demonstrated a net reduction in MA positive urines in participants given mirtazapine. Before moving on to a larger trial, the FDA has requested additional data on the effects mirtazapine on those individuals using both MA and opioids. This drug-drug interaction (DDI) study will provide that data.

Status: Enrollment in this trial has ended and data is currently being analyzed.

Purpose 2: A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection

Relevance: The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there were 1.7 million new HIV infections in 2019, despite efforts to improve HIV testing, linkage to treatment, and prevention. Persistent disparities exist in ongoing HIV incidence in Black, Hispanic/LatinX MSM and TGW populations, with the greatest disparities in Black transgender women in the U.S. and with continued low uptake of PrEP in these disproportionately affected populations globally. These barriers clearly highlight the need for additional PrEP options that may address disparities to PrEP uptake.

Description: Twice a year injections of the medication Lenacapavir have the potential to provide an additional option for populations at risk of HIV acquisition. Lenacapavir can help address substantial existing PrEP barriers including requirements for daily adherence, stigma and concerns about disclosure and discrimination or other social harms, oral medication-associated adverse events, and challenges with access to health care providers in overburdened health systems or in geographical PrEP deserts. Thus, it has the potential to increase the uptake of, adherence to, and thereby the scalability of PrEP in those populations most disproportionately affected by HIV, which will contribute to the overarching goal of ending the epidemic. The primary objective of this study is to evaluate the efficacy of Lenacapavir in preventing the risk of HIV infection.

Status: This study is no longer enrolling new participants. 

Relevance: The fourth wave of the opioid crisis involves increasing polydrug stimulant and opiate use. Incidence of overdose deaths due to polysubstance use involving opioids co-occurring with methamphetamine increased from 2017 to 2018 by 14.6%. According to the National Survey on Drug Use and Health in 2018, an estimated 1,867,000 of persons in US aged 12 years and older, reported methamphetamine use in the past year and 1,051 000 reported substance use disorder in the past year involving methamphetamines.

Description: There are no effective medications for treating methamphetamine use disorder. This proposal will test the superiority of long-acting buprenorphine (and its kappa antagonist activity) over placebo as a treatment for methamphetamine use disorder among persons who co-use opioids.

Status: This study is no longer enrolling.

Relevance: Cocaine is one of the most commonly abused stimulants globally, and in the US, there are signs of a resurgence of cocaine use. A variety of pharmacotherapies for cocaine use disorder (CUD) has been explored but so far, no study has findings robust enough to warrant FDA approval. Recent research suggests that a kappa opioid receptor antagonist can curb the negative emotional states associated with stimulant withdrawal that leads to increased craving and drug-seeking behaviors.

Description: This protocol builds up on results of the Cocaine Use Reduction with Buprenorphine (CURB) study. It aims to evaluate the safety and efficacy of combined monthly injections of XR-NTX and injectable BUP for CUD compared to placebo.

Status: We are currently enrolling. Please call us at 323-461-3106 for additional information or sign up here 

condoms

According to a 1992 study published in the Journal of Sexually Transmitted Diseases, using a condom makes sex 10,000 times safer than not using a condom. The UCLA Vine Street Clinic has partnered with LA County to provide free condoms to the public. For more information, visit http://lacondom.com/find-free-condoms/