Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial.

BACKGROUND: A key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform. METHODS: This randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use. DISCUSSION: If successful, STAMINA's telemedicine approach will significantly reduce the amount of time between SSP clients' initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138-0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

Feasibility Study of Using Mobile Phone-Based Experience Sampling to Assess Drug Checking by Opioid Street Drug Users.

Background: To date, evaluations of take-home fentanyl (and/or benzodiazepine) test strip use - the most common form of drug checking services - and potential effects on overdose risk have relied on retrospective accounts for some preceding time period, usually a week to several months. Such accounts, however, are subject to recall and memory biases. This pilot study assessed the feasibility of using experiential sampling to collect daily information in situ on drug checking and associated overdose risk reduction - the primary outcomes - among a sample of street opioid users and compared the results to retrospective reports. Methods: We recruited 12 participants from a Chicago-based syringe services program. Participants were 18 years of age or older, reported using opioids purchased on the street 3+ times per week in the past month, and had an available Android mobile phone. A phone-based app was programmed to collect daily drug checking information and provided to each participant along with a supply of fentanyl and benzodiazepine test strips and instructions for use over 21 days. Comparable retrospective data were collected via follow-up in-person surveys at the conclusion of daily report collection. Results: We found a reasonably high rate of daily reporting (63.5%) with participants submitting reports on 160 "person-days" out of 252 possible days. Participants submitted daily reports an average of 13 of 21 days. Reports of test strip use frequency varied between the retrospective and daily reports with a relatively higher percentage of days/time using test strips obtained from the daily reports. We also found higher proportions reporting overdose risk reduction behaviors on the daily reports compared with the retrospective reviews. Conclusions: We believe the results support using daily experience sampling to collect information on drug checking behaviors among street drug users. Although resource intensive in comparison to retrospective reports, daily reporting potentially provides more detailed information on test strip use and its association with overdose risk reduction and, ultimately, fewer overdoses. Needed are larger trials and validation studies of daily experience sampling to identify the optimum protocol for collecting accurate information on drug checking and overdose risk reduction behavior.

Feasibility study of using mobile phone-based experience sampling to assess drug checking by opioid street drug users.

BACKGROUND: To date, evaluations of take-home fentanyl (and/or benzodiazepine) test strip use - the most common form of drug checking services - and potential effects on overdose risk have relied on retrospective accounts for some preceding time period, usually a week to several months. Such accounts, however, are subject to recall and memory biases. This pilot study assessed the feasibility of using experiential sampling to collect daily information in situ on drug checking and associated overdose risk reduction - the primary outcomes - among a sample of street opioid users and compared the results to retrospective reports. METHODS: We recruited 12 participants from a Chicago-based syringe services program. Participants were 18 years of age or older, reported using opioids purchased on the street 3 + times per week in the past month, and had an available Android mobile phone. A phone-based app was programmed to collect daily drug checking information and provided to each participant along with a supply of fentanyl and benzodiazepine test strips and instructions for use over 21 days. Comparable retrospective data were collected via follow-up in-person surveys at the conclusion of daily report collection. RESULTS: We found a reasonably high rate of daily reporting (63.5%) with participants submitting reports on 160 "person-days" out of 252 possible days. Participants submitted daily reports an average of 13 of 21 days. Reports of test strip use frequency varied between the retrospective and daily reports with a relatively higher percentage of days/time using test strips obtained from the daily reports. We also found higher proportions reporting overdose risk reduction behaviors on the daily reports compared with the retrospective reviews. CONCLUSIONS: We believe the results support using daily experience sampling to collect information on drug checking behaviors among street drug users. Although resource intensive in comparison to retrospective reports, daily reporting potentially provides more detailed information on test strip use and its association with overdose risk reduction and, ultimately, fewer overdoses. Needed are larger trials and validation studies of daily experience sampling to identify the optimum protocol for collecting accurate information on drug checking and overdose risk reduction behavior.

Validated method for the analysis of 22 illicit drugs and their metabolites via liquid chromatography tandem mass spectrometry (LC-MS/MS) in illicit drug samples collected in Chicago, IL.

Drug checking services are being utilized worldwide to provide people who use drugs information on the composition and contents of their drugs as a tool for harm reduction and accidental overdose prevention. Existing drug checking services use a variety of techniques including immunoassay strips and spectroscopic techniques like FTIR and Raman. Few services utilize LC-MS based methods for primary or secondary analysis and few methods exist for direct analysis of illicit drugs. To address this, an LC-MS/MS method was developed for 22 illicit drugs and cutting agents using LC-MS/MS with application to 124 illicit drug samples that were collected from Chicago, IL. Samples were also analyzed using fentanyl and benzodiazepine immunoassay test strips. Fentanyl test strips gave a positive result for 86% of samples with only one sample showing a positive result on a benzodiazepine test strip. LC-MS/MS analysis of samples show that opioids were the most commonly quantified in 96% of samples, followed by stimulants at 12% and benzodiazepines at 1%. Fentanyl was measured in 91% of samples, co-occurring with heroin in 58% of opioid-containing samples. A comparison of the gold-standard LC-MS/MS results to fentanyl test strips shows a high level of accuracy for the fentanyl test strips, with just 5% of samples being classified as false negatives and no false positives. These results demonstrate the strengths and benefits of LC-MS/MS when incorporated as a secondary analysis tool for drug checking.