Study Results
Clinical Trials
M3.0
2021-2023
24 participants
M3 was a Phase I clinical trial looking at the safety of offering Mirtazapine, an antidepressant drug, to individuals who are active methamphetamine users. Study participants were closely monitored for 16 days in a hospital setting to evaluate the safety of taking Mirtazapine while using methamphetamine. A subset of the study participants who were prescribed methadone and used methamphetamine were also evaluated to see if the use of mirtazapine worked for people who may be using both meth and opioids. Ultimately, there were no safety concerns or drug-to-drug interactions found that would limit further development of Mirtazapine as a treatment for methamphetamine use disorder.
Lasso
2022-2024
260 participants
LASSO wanted to understand factors leading to deaths from acute stimulant toxicity. First, 200 people who knew someone well who had a fatal overdose involving stimulants such as methamphetamine or cocaine. They had a one-time interview where they answered questions about the decedent's life events, personality, health history, substance use, and more. 60 people who currently use stimulants we interviewed about the same topics. The goal was to contribute to the eventual design of interventions to reduce stimulant overdose mortality.
LASSO produced extensive findings to better understand the nature of deaths attributed to acute stimulant toxicity. We learned that stimulant deaths involving fentanyl generally resembled fentanyl overdose deaths. In fact, the loved ones of the decedents did not consider their deaths to be due to acute toxicity, but premature aging. We gained a far greater understanding of the preeminent roles of cardiovascular disease, housing, and social isolation on progression to death.
Reboot 2.0
2019-2022
268 participants
REBOOT 2.0 was a randomized controlled trial to assess the feasibility, acceptability, and effectiveness of Informational-Motivational-Behavioral-(IMB) based counseling to reduce opioid overdose risk among individuals who use opioids. Participants were randomized to receive 30-45 minutes of overdose prevention, IMB counseling, or placebo. The study took place in San Francisco and Boston. Participants were seen every 4 months for 16 months.
Ultimately, we found that REBOOT did not influence overdose event frequency in two cities with street drug markets dominated by fentanyl and in the setting of extensive naloxone availability and harm reduction programming. It remains possible that this intervention influences overdose frequency in the setting of less potent opioids, or settings with less overdose prevention programs available.
ADAPT-2
2017-2018
403 participants (59 CSUH)
ADAPT-2 was a NIDA Clinical Trials Network randomized controlled trial to determine the efficacy of bupropion plus extended-release naltrexone for the treatment of methamphetamine use disorder, for which CSUH served as a site. Participants were randomized to receive daily high-dose bupropion, with video-monitored and incentivized adherence, plus extended-release naltrexone every 3 weeks, or placebo. The study had an adaptive component, in which some participants in the placebo arm were transitioned to active treatment halfway through the trial. Participants randomized to active treatment were more likely to have 3 out of the last 4 urine samples negative for methamphetamine.
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, the following phase III study, was then conducted from 2019-2022.
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.
COPING
2016-2021
300 participants
COPING was a prospective cohort study of 300 patients receiving long-term opioid therapy for chronic, non-cancer pain. COPING has identified predictors of satisfaction with pain management, a unique role of stimulant use in pain self-treatment, the role of patient race in predicting opioid management decisions, and the impact of discontinuation of opioid therapy on quality of care indicators.
Opioid Discontinuation Study (ODS)
2012-2019
600 participants
ODS was a chart review study of 300 patients living with HIV and 300 demographically-matched patients without HIV who had received at least 3 consecutive months of opioid therapy for chronic pain. ODS analyses have documented negative effects on engagement in HIV care when opioid therapy is discontinued. In addition, ODS found that, whereas testing positive for stimulants is not associated with opioid-related emergency medical care, those patients who test positive for stimulants are still more likely to be discontinued from opioid therapy.
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 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 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 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.