Study Results

Clinical Trials

BYE-C

2015-2017

31 participants

Bye-C was a randomized controlled trial comparing modified directly-observed treatment (mDOT) to unobserved dosing for treating chronic hepatitis C infection among people who actively inject drugs with others (to maximize the potential to reduce secondary transmission). Participants were randomized to mDOT or unobserved daily dosing of ledipasvir-sofosbuvir (Harvoni) for 8-weeks. Reinfection was measured at 12 and 36-week follow-up visits. 90% of patients had sustained viral response at 12 weeks with no differences between arms, suggesting that both dosing methods may be effective in achieving successful treatment.

M2.0

2013-2017

120 participants

M2.0 was a randomized controlled trial to determine the efficacy of mirtazapine for the treatment of methamphetamine use disorder and reduction in HIV risk behavior among MSM and transwomen. Participants were randomized to receive a daily dose of mirtazapine or placebo for 6 months. Results from the study showed that mirtazapine reduced methamphetamine use and some HIV risk behaviors among MSM and transwomen, with benefits extending post-treatment. Mirtazapine is the first medication to demonstrate efficacy in treating methamphetamine use disorder in two independent randomized trials.

REBOOT

2014-2016

63 participants

REBOOT was a pilot, randomized controlled trial to assess the effectiveness of motivational-interviewing-based counseling on reducing overdose events among people who use opioids. Participants were randomized to receive counseling or “treatment as usual” (e.g. referrals) and attended follow-up visits every 4 months for 16 months. Results from this study found that participants who received the counseling intervention had significantly fewer overdose events over the course of the study than those in the control group. A follow-up study, REBOOT 2.0, is actively enrolling in San Francisco and Boston.

TREX

2012-2015

100 participants

TREX was a randomized controlled trial to assess the effectiveness of extended-release naltrexone on reducing methamphetamine use and sexual risk behaviors in a group of methamphetamine-dependent MSM. Participants were randomized to receive extended-release naltrexone or placebo. Results from this study indicate that extended-release naltrexone may not reduce methamphetamine use or sexual risk behaviors in methamphetamine-dependent MSM compared with placebo.

Project iN

2013-2014

30 Participants

Project iN was a randomized controlled trial to assess the acceptability and tolerability of using targeted naltrexone to reduce methamphetamine use among non-dependent methamphetamine-using, binge-drinking MSM at high-risk for HIV. The results from Project iN found that naltrexone was associated with significant sexual risk reductions; and for some individuals, naltrexone was associated with meth and binge-drinking reductions.

NIP

2013-2014

11 participants

NIP was a pilot study to assess the feasibility, efficacy, and acceptability of using extended-release naltrexone (XRNTX) as a stand-alone treatment for severe alcohol use disorder. 88% of participants reported that XRNTX helped reduce their drinking. While the study was limited to a small sample size, results showed modest reductions on Urge-to-Drink scores and costs of emergency medical services utilized for patients who received XRNTX. 

Project ECHO

2010-2012

326 participants

Project ECHO was a behavioral study to assess the efficacy of adapting Personalized Cognitive Counseling (PCC) to address self-justifications for high-risk sex among HIV-negative, substance-using MSM. Results from this study did not find evidence that PCC reduced sexual risk behaviors overall but did observe significant reductions in unprotected anal intercourse events among non-dependent substance-using MSM. Based on study findings, the CDC led an update to the PCC manual to include a discussion of substance use and PrEP during the PCC session.

Aripiprazole

2009-2012

90 participants

Aripiprazole was a randomized controlled trial to assess the effectiveness of using aripiprazole to reduce methamphetamine use among individuals actively using methamphetamine. Participants were randomized to receive aripiprazole or placebo for 12 weeks concurrent with weekly counseling. Results did not find a significant difference in methamphetamine use reduction in either study arm.

M1.0

2007-2010

60 participants

M1 was a pilot, randomized controlled trial to assess the effectiveness of using daily mirtazapine to reduce methamphetamine use among MSM. Participants were randomized to receive a daily dose of mirtazapine or placebo for 12 weeks concurrent with weekly counseling. Results found a reduction in methamphetamine use among participants that took daily mirtazapine compared to placebo.

Bupropion

2006-2007

30 participants

Bupropion was a randomized controlled trial to assess the feasibility of enrolling and retaining methamphetamine-dependent MSM in a pharmacologic intervention trial. Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion or placebo for 12 weeks. Study participation and retention rates were high—90% and 81%, respectively—indicating that it is feasible to enroll and retain this population in a pharmacologic trial. Medication adherence was moderate (60%), suggesting that improved adherence support is necessary to evaluate the efficacy of bupropion for methamphetamine dependence in MSM.

TRANSITIONS

2012-2018

602 participants

TRANSITIONS was a retrospective cohort study among publicly insured primary care patients in San Francisco who had been prescribed opioids for chronic non-cancer pain for at least 3 consecutive months. Results show an increase in the frequency of heroin and non-prescribed opioid pain reliever use among participants discontinued from prescribed opioids compared to participants with unchanged opioid prescriptions. Additionally, participants whose opioid pain reliever dose increased were more likely to use heroin more frequently. 

SEEDS

2015-2017

252 participants

SEEDS was a respondent-driven sampling study to examine heavy alcohol use patterns among MSM and to analyze the correlates of hazardous alcohol consumption and binge drinking. Results showed heavy alcohol use patterns were common and independently associated with a greater number of male sexual partners and sexually transmitted infections. Moreover, significant racial/ethnic and socioeconomic disparities related to heavy alcohol use were observed and race/ethnicity modified the effect of the risk factors associated with these outcomes.

NOSE

2013-2016

1,985 participants

NOSE was an implementation science study to assess the feasibility and acceptability of co-prescribing naloxone to patients receiving opioids for chronic non-cancer pain. Results from this study showed that patients who received a naloxone prescription had 47% fewer opioid-related emergency department visits in the 6 months after receipt of the prescription and 63% fewer visits after 1 year compared to patients who did not receive naloxone.

ADIOS

2015

40 participants

ADIOS was a pilot randomized controlled trial to assess the feasibility and acceptability of using academic detailing as an educational intervention to increase naloxone prescribing among primary care providers in San Francisco. The study found that providers who received academic detailing had a significantly greater increase in naloxone prescribing compared to providers who did not receive the intervention.

LERNT

2014

114 participants

LERNT was an intervention study to determine if a brief educational training was sufficient to educate naloxone recipients on overdose recognition, management, and administration. First-time naxolone recipients and refill recipients were given a 5-10 minute standardized education at four Drug Overdose Prevention and Education sites in San Francisco. Results indicate that comfort with recognition of, response to, and administration of naloxone for an overdose event significantly increased after brief education among first-time recipients. Additionally, both first-time and refill recipients demonstrated a high level of knowledge regarding opioid overdose recognition and response, suggesting that brief education is sufficient to improve comfort and facility in recognizing and managing overdose.

Non-Clinical Trials

San Francisco Department of Public Health

25 Van Ness Avenue, Suite 500
San Francisco, CA 94102

Email: csuh.studies@sfdph.org

Tel: 628-217-6232

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CSUH is a program of the San Francisco Department of Public Health