Dataset Information

Injectable pharmacotherapy for opioid use disorders (IPOD).

ABSTRACT: Despite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD).Opioid-dependent inmates will be randomly assigned to one of three treatment conditions before being released to the community to include: 1) XR-NTX only; 2) XR-NTX plus patient navigation (PN), and 3) enhanced treatment-as-usual (ETAU) with drug education and a community treatment referral. Before release from jail, participants in the XR-NTX and XR-NTX plus PN conditions will receive their first XR-NTX injection. Those in the XR-NTX plus PN condition also will meet with a patient navigator. Participants in both XR-NTX conditions will be scheduled for medical management sessions twice monthly for months 1-3, monthly medical management sessions for months 4-6, with monthly injections for 5months post-release (which, given the pre-release injection, results in a 6-month medication phase). Follow-up data collection will occur at 1, 3, 6, and 12months post release.We discuss the study's rationale, aims, methods, and anticipated findings. The primary outcome is the presence of a DSM 5 OUD diagnosis 1year after randomization (6months after the end of the active treatment phase).We hypothesize that providing XR-NTX prior to release from jail will be particularly beneficial for this extremely high-risk population by reducing opioid use, associated criminal behavior, and injection-related disease risk. ClinicalTrials.Gov: NCT02110264.

SUBMITTER: Farabee D

PROVIDER: S-EPMC5550768 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Injectable pharmacotherapy for opioid use disorders (IPOD).

Farabee David D Hillhouse Maureen M Condon Timothy T McCrady Barbara B McCollister Kathryn K Ling Walter W

Contemporary clinical trials 20160606

<h4>Background</h4>Despite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD).<h4>Methods</h4>Opioid-dependent inmates will be randomly assigned to one ...[more]

PMID: 27282118

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Project description:AIMS:To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined. METHODS:We searched PubMed and used Google Scholar for forward citation searches of peer-reviewed papers from January 2006 to June 2017. Studies that included individuals seeking treatment for opioid use disorder who were offered XR-NTX were included. RESULTS:We identified and included 34 studies. Pooled estimates showed that XR-NTX induction success was lower in studies that included individuals that required opioid detoxification [62.6%, 95% confidence interval (CI) = 54.5-70.0%] compared with studies that included individuals already detoxified from opioids (85.0%, 95% CI = 78.0-90.1%); 44.2% (95% CI = 33.1-55.9%) of individuals took all scheduled injections of XR-NTX, which were usually six or fewer. Adherence was higher in prospective investigational studies (i.e. studies conducted in a research context according to a study protocol) compared to retrospective studies of medical records taken from routine care (6-month rates: 46.7%, 95% CI = 34.5-59.2% versus 10.5%, 95% CI = 4.6-22.4%, respectively). Compared with referral to treatment, XR-NTX reduced opioid use in adults under criminal justice supervision and when administered to inmates before release. XR-NTX reduced opioid use compared with placebo in Russian adults, but this effect was confounded by differential retention between study groups. XR-NTX showed similar efficacy to buprenorphine when randomization occurred after detoxification, but was inferior to buprenorphine when randomization occurred prior to detoxification. CONCLUSIONS:Many individuals intending to start extended-release naltrexone (XR-NTX) do not and most who do start XR-NTX discontinue treatment prematurely, two factors that limit its clinical utility significantly. XR-NTX appears to decrease opioid use but there are few experimental demonstrations of this effect.

Project description:BACKGROUND:Patients recovering from opioid use disorders (OUD) may be prone to relapse and opioid misuse in the postoperative period due to re-exposure to prescription opioids for pain control. This retrospective study analyzed the incidence of confirmed opioid misuse in the postoperative period in patients with OUDs enrolled in an opioid agonist treatment (OAT) program. METHODS:The study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016. The patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission. The surgical group consisted of veterans who had surgery or an invasive procedure during their enrollment in the OAT program. The control (reference) group consisted of enrolled veterans who did not have any invasive procedure. The primary outcome was the first opioid misuse within 365?days after surgery date in the surgical group or a randomly assigned sham surgery date in controls. Opioid misuse was defined as either inappropriate use of opioids detected via urinalysis or admission with a diagnosis of an opioid overdose. RESULTS:From a total of 1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180?days after admission to the OAT program. Of the 923 eligible patients, 87 had surgery while enrolled and 836 did not. Using propensity scores, all 87 of the surgical cases were matched to 249 of the control cases. In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p?=?0.034) in logistic regression. CONCLUSION:Among patients with a history of opioid use disorders, the postoperative period was associated with an increased risk of opioid misuse. Moreover, opioid misuse among patients in an opioid agonist treatment program may well be considered a surgical hazard.

Project description:BACKGROUND:The U.S. is facing an opioid epidemic, but despite mandates for pharmacotherapy for opioid use disorder to be available at Veterans Health Administration (VHA) facilities, the majority of veterans with opioid use disorder do not receive these medications. In implementation research, facilities are often targeted for qualitative inquiry or quality improvement efforts based on quality measure performance during a one-year period. However, sites that experience quality performance changes from one year to the next may be highly informative because mechanisms that impact facility change may be more discoverable. The current study examined changes in receipt of pharmacotherapy for opioid use disorder in a national healthcare system to determine the extent to which sites fluctuated in performance over a two-year period and illustrate how changes in quality measures over time may be useful for implementation research and healthcare surveillance of quality measures. METHODS:Using national VHA data from Fiscal Years (FY) 2016 and 2017, we calculated quality measure performance as the number of patients who received pharmacotherapy for opioid use disorder (i.e., methadone, buprenorphine, and naltrexone) divided by the number of patients with a current non-remitted opioid use disorder diagnosis for each FY at each facility (n?=?129) and examined change from FY16 to FY17. RESULTS:The mean rate of receipt of pharmacotherapy for opioid use disorder was 38% (facility range?=?3% to 74%) in FY16 and 41% (facility range?=?2% to 76%) in FY17. The average facility-level change in performance was 3% and ranged from -19% to 26%. There were 32 facilities that decreased in provision of pharmacotherapy, 12 facilities with no change, and 85 facilities that increased. CONCLUSIONS:For facilities with average or high performance, it was difficult to maintain their performance over time. Identifying and learning from facilities with recent fluctuations may be more informative to guide the design of future quality improvement efforts than studying facilities with stable high or low performance.

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Injectable pharmacotherapy for opioid use disorders (IPOD).

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Injectable pharmacotherapy for opioid use disorders (IPOD).

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