The source (or study) population for our analyses was the pooled study sample of participants in two multisite CTN treatment trials: 0051 (X:BOT [10 (link)]; 2014–2017) and 0067 (CHOICES [34 (link)]; 2018–2019). Information on each study, including inclusion/exclusion criteria and recruitment and enrollment data are presented in Additional file 1 : Table S1. Briefly, X:BOT randomized participants to XR-NTX vs. sublingual buprenorphine in inpatient, medically monitored opioid treatment facilities. CHOICES randomized to XR-NTX vs. treatment as usual in outpatient HIV clinics. However, 93% of treatment-as-usual participants who initiated treatment received buprenorphine; to create a more homogeneous pooled source population, eight CHOICES participants receiving methadone and three receiving only oral naltrexone were excluded. All X:BOT participants were included (corresponding to the original intent-to-treat sample). In both studies, participants provided urine drug screen (UDS) and harmonized questionnaire, and clinical, pharmacy, or laboratory data weekly (X:BOT) or every 4 weeks (CHOICES) for 24 weeks.
We defined three target populations for our analyses. The first is a nationally-representative sample of civilian, housed, noninstitutionalized adults with OUD identifying the need for treatment, as characterized by the NSDUH household 2018 and 2019 survey years [35 ]. Among all NSDUH respondents, we included those who had OUD, were age 18 or older, and (1) received treatment in the past year, but used nonprescribed opioids in the past month or (2) identified the need for, but had not received, treatment. The second target population was people receiving or planning to receive MOUD treatment, as captured in the 2018 TEDS admissions dataset [36 ]. Treatment episodes were included if the individual entering treatment met diagnostic criteria for OUD based off the Diagnostic and Statistical Manual of Mental Disorder—5th edition (DSM-5), used heroin or other illicit opioids in the past month, was 18 or older, and had MOUD as part of their intended treatment plan. The third target population was people who inject drugs or misuse opioids in rural areas of the U.S. as characterized by eight sites participating in the ROI [37 (link)]. Briefly, the ROI is a consortium of harmonized studies of people who use drugs in rural counties with high overdose rates covering ten states (Illinois, Kentucky, North Carolina, New England [Massachusetts, New Hampshire, Vermont], Ohio, Oregon, West Virginia, Wisconsin). Inclusion criteria varied slightly by study site, but generally, people were eligible for the ROI cohort if they reported IDU or use of opioids to “get high” in the past month. ROI participants were included in this analysis if they were 18 or older and used opioids to get high in the past month. In order to meet positivity assumptions (i.e., to avoid generalizing to people who are strictly excluded from the source population of clinical trials), we also restricted all three target populations to individuals who were English-speaking, not currently pregnant, and without suicidal ideation.
We defined three target populations for our analyses. The first is a nationally-representative sample of civilian, housed, noninstitutionalized adults with OUD identifying the need for treatment, as characterized by the NSDUH household 2018 and 2019 survey years [35 ]. Among all NSDUH respondents, we included those who had OUD, were age 18 or older, and (1) received treatment in the past year, but used nonprescribed opioids in the past month or (2) identified the need for, but had not received, treatment. The second target population was people receiving or planning to receive MOUD treatment, as captured in the 2018 TEDS admissions dataset [36 ]. Treatment episodes were included if the individual entering treatment met diagnostic criteria for OUD based off the Diagnostic and Statistical Manual of Mental Disorder—5th edition (DSM-5), used heroin or other illicit opioids in the past month, was 18 or older, and had MOUD as part of their intended treatment plan. The third target population was people who inject drugs or misuse opioids in rural areas of the U.S. as characterized by eight sites participating in the ROI [37 (link)]. Briefly, the ROI is a consortium of harmonized studies of people who use drugs in rural counties with high overdose rates covering ten states (Illinois, Kentucky, North Carolina, New England [Massachusetts, New Hampshire, Vermont], Ohio, Oregon, West Virginia, Wisconsin). Inclusion criteria varied slightly by study site, but generally, people were eligible for the ROI cohort if they reported IDU or use of opioids to “get high” in the past month. ROI participants were included in this analysis if they were 18 or older and used opioids to get high in the past month. In order to meet positivity assumptions (i.e., to avoid generalizing to people who are strictly excluded from the source population of clinical trials), we also restricted all three target populations to individuals who were English-speaking, not currently pregnant, and without suicidal ideation.
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