Completed Studies

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.

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 75 BMSM over a one-year period.

OUTCOMES: Key findings may be found at this link.

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 M, DeYoung D, Swanson AN, Heinzerling KG, Shoptaw S. Varenicline for the treatment of methamphetamine dependence. Drug and Alcohol Dependence. 2015 Nov 1;156:e28.

PERCEPTIONS OF AND 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 adopt PrEP compared to older BMSM (30+ years). Only a third of participants were aware of PrEP, and no participant had ever used PrEP. Negative perceptions were associated with a lower PrEP adoption intention and included being uncomfortable taking an HIV medicine when HIV-negative and not knowing if there are long-term side effects of taking an HIV medication.

1. Brooks, R. A., Landovitz, R. J., Regan, R., Lee, S. J., & Allen, V. C. (2015). Perceptions of and intentions to adopt HIV pre-exposure prophylaxis among black men who have sex with men in Los Angeles. International Journal of STD & AIDS. EPub 2015 Jul 26. PMID: 25638214.

USING ONLINE SOCIAL NETWORKS FOR HIV PREVENTION IN AFRICAN AMERICAN/LATINO MSM

DESCRIPTION: This randomized trial is designed to test the feasibility of using social networking technologies for HIV prevention among African American and Latino men who have sex with men (MSM) in Los Angeles. Findings from this study will be used to prepare for a larger intervention to assess whether online social networking technologies can be used for HIV prevention among high-risk populations.

OUTCOMES: Further analysis is underway. Several publications have utilized data collected from this study to test various online intervention methods:

    1. 1. Young SD, Shakiba A, Kwok J, Montazeri MS. The influence of social networking technologies on female religious veil-wearing behavior in Iran. Cyberpsychol Behav Soc Netw. 2014 May;17(5):317-21. doi:10.1089/cyber.2013.0338. Epub 2014 Mar 10. PMID: 24611768.
    2. 2. Young SD, Zhao M, Teiu K, Kwok J, Gill H, Gill N. A social-media based HIV prevention intervention using peer leaders. J Consum Health Internet. 2013 Oct 1;17(4):353-361. PMID: 24526928.
    3. 3. Young SD, Rivers C, Lewis B. Methods of using real-time media technologies for detection and remote monitoring of HIV outcomes. Prev Med. 2014 Jun;63:112-5. doi: 10.1016/j.ypmed.2014.01.024. Epub 2014 Feb 8. PMID: 24513169.

For a complete list, click here.

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.

OUTCOMES: Though this study has completed enrollment, data analysis is underway. Preliminary outcomes of the trial were presented at the 2013 College of Problems on Drug Dependence Conference in San Diego. Click here to read the press release and stay tuned for additional results.

DeYoung, D. Z., Heinzerling, K. G., Swanson, A. N., Tsuang, J., Furst, B. A., Yi, Y., … & Shoptaw, S. J. (2016). Safety of Intravenous Methamphetamine Administration During Ibudilast Treatment. Journal of clinical psychopharmacology. 2016 Aug;36(4):347-54. doi: 10.1097/JCP.0000000000000511.

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 for treatment seeking, methamphetamine-dependent persons has been completed and we are analyzing the samples and data collected.

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

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 50% higher than in White MSM in the U.S. Even more alarming, HPTN061 found that young Black MSM—those 30 years of age and younger—acquired HIV infection at a rate of 5.9% per year, three times the rate among US White MSM. The overall infection rate among Black MSM in this US study is comparable to the rate seen in the general populations of countries in sub-Saharan Africa hardest hit by the HIV epidemic. Further results can be found here.

Two publications have since been released using data gathered from the HPTN061 Study:

1. Koblin, B., Mayer K., Eshleman, S., Wang, L., Mannheimer, S., del Rio, C., Shoptaw, S., Magnus, M., Buchbinder, S., Wilton, L., Ting-Yuan, L., Cummings, V., Piwowar-Manning, E., Fields, S., Griffith, S., Elharrar, V., Wheeler, D., for the HPTN 061 Protocol Team. Correlates of HIV acquisition in a cohort of black men who have sex with men in the United States: HIV Prevention Trials Network (HPTN) 061. PLoS ONE 8(7): e70413. doi:10.1371/journal.pone.0070413

2. Dyer, T.P., Regan, R., Wilton, L., Harawa, N.T., Ou, S.S., Wang, L., Shoptaw, S. Differences in substance use, psychosocial characteristics and HIV-related sexual risk behavior between black men who have sex with men only (BMSMO) and black men who have sex with men and women (BMSMW) in six US cities. Journal of Urban Health. 2013 Jul 30 (Epub ahead of print) PMCID: PMC in progress.

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 study provided significantly fewer methamphetamine-free urine tests compared to participants receiving placebo and males respectively. Results do not support the feasibility of additional trials of bupropion for adolescent methamphetamine abuse/dependence. Future studies should investigate the influence of gender on adolescent methamphetamine abuse and treatment outcomes. This study was funded by the National Institute on Drug Abuse grant number R21 DA026513.

A publication has been released using data gathered from this study:

1. Heinzerling KG, Gadzhyan J, van Oudheusden H, Rodriguez F, McCracken J, Shoptaw S. Pilot randomized trial of bupropion for adolescent methamphetamine abuse/dependence. J Adolesc Health. 2013 Apr;52(4):502-5.

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 of cognitive-behavioral motivational enhancement (CBME) and were offered up to 4 weeks of nicotine replacement therapy (NRT).

OUTCOMES: Participants reported significant declines in withdrawal and nicotine dependence scores during the course of the study period. Compared with baseline, youths reported lower scores on the MNWS (withdrawal) and CDS-12 (dependence) at the last intervention visit (week 6) and at each of the follow up visits (weeks 12, 16, and 24). In addition, youths self-reported smoking fewer cigarettes per day in the preceding week (7-day smoking point prevalence) at each of these study points compared with baseline smoking.

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; N= 36) or placebo (twice daily; N= 37) for 12-weeks under double-blind conditions. Participants attended clinic thrice weekly to provide urine samples analyzed for MA-metabolite, to complete research measures and assessments, and to receive contingency management and weekly cognitive behavioral therapy sessions.

OUTCOMES: There were no statistically-significant effects for bupropion relative to placebo on MA use verified by urine drug screens, for reducing the severity of depressive symptoms or MA-cravings, or on study retention. In a post hoc analysis, there was a statistically-significant effect of bupropion treatment on MA use among participants with lighter (0–2 MA-positive urines), but not heavier (3–6 MA-positive urines) MA use during baseline. Bupropion treatment was also associated with significantly reduced cigarette smoking, by almost five cigarettes per day (p = 0.0002). Bupropion was no more effective than placebo in reducing MA use in planned analyses, though bupropion did reduce cigarette smoking. Post hoc findings of an effect for bupropion among baseline light, but not heavy, MA users suggests further evaluation of bupropion for light-MA users is warranted.

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 SATHCAP here: http://www.icpsr.umich.edu/icpsrweb/NAHDAP/studies/29181.

OUTCOMES: Due in part to the use of respondent-driven sampling, the average participant in this study was surprisingly older (early 40’s), male, African American or Latino, unemployed and marginally housed, with a majority reporting drug use within the last 30 days. Rates of HIV infection here high. Findings from this study were used to advise development and roll-out of the HPTN 061 and 073 trials at the UCLA Vine Street Clinic. It also preceded the MASCULINE Cohort, rolling out in 2014.

1. King WD, Larkins S, Hucks-Ortiz C, Wang PC, Gorbach PM, Veniegas R, Shoptaw S. Factors Associated with HIV Viral Load in a Respondent Driven Sample in Los Angeles. AIDS Behavior. 2009 Feb;13(1):145-53. PMCID: PMC2649661

2. Gorbach PM, Murphy, R, Weiss RE, Hucks-Ortiz C, Shoptaw S. Bridging Sexual Boundaries: Men Who Have Sex With Men and Women in a Street-Based Sample in Los Angeles. Jrnl of Urban Health. 2009 July; 86 Suppl 1:63-76. PMCID: PMC2705489

3. Ober A, Shoptaw S, Wang PC, Gorbach PM, Weiss RE. Factors Associated with Event-Level Stimulant Use during Sex In a Sample of Older, Low-Income Men Who Have Sex with Men in Los Angeles. Drug and Alcohol Dependence, 2009 Jun 1;102(1-3):123-9. PMCID: PMC2751657

4. Shoptaw S, Weiss RE, Munjas B, Hucks-Ortiz C, Young SD, Larkins S, Victorianne GD, Gorbach PM. Homonegativity, Substance Use, Sexual Risk Behaviors, and HIV Status in Poor and Ethnic Men Who Have Sex With Men in Los Angeles. Jrnl of Urban Health. 2009 July; 86 Suppl 1:77-92. PMCID: PMC2705491

5. Young SD, Shoptaw S, Weiss RE, Munjas B, Gorbach PM. Predictors of Unrecognized HIV Infection Among Poor and Ethnic Men Who Have Sex with Men in Los Angeles. AIDS and Behavior. 2009 December 31. PMCID: PMC3029495

6. Iguchi MY, Ober AJ, Berry SH, Fain T, Heckathorn DD, Gorbach PM, Heimer R, Kozlov A, Ouellet LJ, Shoptaw S, Zule WA. Simultaneous recruitment of drug users and men who have sex with men in the United States and Russia using respondent-driven sampling: sampling methods and implications. J Urban Health. 2009 Jul;86 Suppl 1:5-31. PMCID: PMC2705484

7. Murphy RD, Gorbach PM, Weiss RE, Hucks-Ortiz C, Shoptaw SJ. Seroadaptation in a sample of very poor Los Angeles area men who have sex with men. AIDS Behav. 2013 Jun;17(5):1862-72. PMCID: PMC3479326

8. Ober AJ, Iguchi MY, Weiss RE, Gorbach PM, Heimer R, Ouellet LJ, Shoptaw S, Anglin MD, Zule WA. The relative role of perceived partner risks in promoting condom use in a three-city sample of high-risk, low-income women. AIDS Behav. 2011 Oct;15(7):1347-58.

 

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 was not a significant predictor of HPV infection.

  1. Cranston RD, Murphy R, Weiss RE, Da Costa M, Palefsky J, Shoptaw S, Gorbach PM. Anal human papillomavirus infection in a street-based sample of drug using HIV-positive men. Int J STD AIDS. 2012 Mar;23(3):195-200. PMC in progress.

 

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 findings, the frequency of high level drug resistance was over 40% in individuals with viral loads > 500 copies/ml. This suggests that in this sample, treatment response is highly polarized. Analyses suggest relatively little clustering of HIV sequences, despite HIV+ individuals having an extremely high odds (>25%) of recruiting other HIV+ individuals, suggesting that there is little overlap between HIV transmission networks and recruitment by respondent-driven sampling. This also is consistent with HIV+ individuals reporting not having sex with their recruiter. This supplement helped to develop a statistical package, written in the R programming language, which imports RDS data, and generates figures depicting the recruitment networks, and generates sample, equilibrium and population estimates of quantities of interest, such as HIV prevalence.

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, and adherence to regimens with various HIV medication.

OUTCOMES: Findings from this project are particularly significant in that clinicians need evidence to guide decisions regarding whether or not to provide active substance using MSM with access to HAART medications. The reports from these efforts are the best controlled evidence showing that HAART medications swamp the significant effects of methamphetamine on HIV disease progression. Findings are highly significant in that they yield strong support for providing access to HAART medications for HIV-seropositve men who use stimulants.

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 geographical location of HIV-related tweets. There was a significant positive relationship (p < .01) between HIV-related tweets and HIV cases. Results suggest the feasibility of using social networking data as a method for devaluating and detecting HIV risk behaviors and outcomes.

  1. Young SD, Rivers C, Lewis B. Methods of using real-time social media technologies for detection and remote monitoring of HIV outcomes. Preventive Medicine. 2014 8 Feb (Epub Ahead of Print). PMC ID: PMC in progress.

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