Dataset Information

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

ABSTRACT: BACKGROUND:Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings. METHODS:Male and female individuals under probation or parole supervision (N?=?320) with histories of opioid use disorder will be enrolled in this randomized controlled trial. Participants will be randomized to one of two study arms: Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine using the MedicaSafe dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to a community program; or Treatment as Usual (TAU): Participants will receive a referral to buprenorphine pharmacotherapy treatment in the community. Treatment outcomes will be: (a) illicit opioid oral saliva drug test results; and (b) treatment adherence (i. entered community based treatment; ii. number of days receiving opioid treatment). RESULTS:We describe the background and rationale for the study, its aims, hypotheses, and study design. CONCLUSIONS:If shown to increase compliance rates with conditions of probation and parole, buprenorphine treatment co-located at community supervision field offices could have a major impact on delivery of buprenorphine treatment to the criminal justice population. The public health impact of the proposed study would be widespread because this intervention could be implemented throughout areas of the US.

SUBMITTER: Gordon MS

PROVIDER: S-EPMC6436986 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

Gordon Michael S MS Vocci Frank J FJ Taxman Faye F Fishman Marc M Sharma Bikash B Blue Thomas R TR O'Grady Kevin E KE

Contemporary clinical trials 20190220

<h4>Background</h4>Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings.<h4>Methods</h4>Male and female individuals under probation ...[more]

PMID: 30797042

Similar Datasets

Project description:BackgroundWe hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT).MethodsWe used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours.ResultsWe included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short.ConclusionsWe found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.Trial registration numberURL: https://www.Clinicaltrialsgov ; Unique identifier: NCT03192332.

Project description:Buprenorphine opioid agonist treatment (OAT) has established efficacy for treating opioid dependency among persons seeking addiction treatment. However, effectiveness for out-of-treatment, hospitalized patients is not known.To determine whether buprenorphine administration during medical hospitalization and linkage to office-based buprenorphine OAT after discharge increase entry into office-based OAT, increase sustained engagement in OAT, and decrease illicit opioid use at 6 months after hospitalization.From August 1, 2009, through October 31, 2012, a total of 663 hospitalized, opioid-dependent patients in a general medical hospital were identified. Of these, 369 did not meet eligibility criteria. A total of 145 eligible patients consented to participation in the randomized clinical trial. Of these, 139 completed the baseline interview and were assigned to the detoxification (n?=?67) or linkage (n?=?72) group.Five-day buprenorphine detoxification protocol or buprenorphine induction, intrahospital dose stabilization, and postdischarge transition to maintenance buprenorphine OAT affiliated with the hospital's primary care clinic (linkage).Entry and sustained engagement with buprenorphine OAT at 1, 3, and 6 months (medical record verified) and prior 30-day use of illicit opioids (self-report).During follow-up, linkage participants were more likely to enter buprenorphine OAT than those in the detoxification group (52 [72.2%] vs 8 [11.9%], P?<?.001). At 6 months, 12 linkage participants (16.7%) and 2 detoxification participants (3.0%) were receiving buprenorphine OAT (P?=?.007). Compared with those in the detoxification group, participants randomized to the linkage group reported less illicit opioid use in the 30 days before the 6-month interview (incidence rate ratio,?0.60; 95% CI, 0.46-0.73; P?<?.01) in an intent-to-treat analysis.Compared with an inpatient detoxification protocol, initiation of and linkage to buprenorphine treatment is an effective means for engaging medically hospitalized patients who are not seeking addiction treatment and reduces illicit opioid use 6 months after hospitalization. However, maintaining engagement in treatment remains a challenge.clinicaltrials.gov Identifier: NCT00987961.

Project description:In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered.We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system.Sublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to approximately 0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated.Buprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome.

Project description:ContextNo randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence.ObjectiveTo evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids.DesignMultisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week postmedication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week postmedication follow-up.SettingTen US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription opioids.InterventionsIn both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone.Main outcome measuresPredefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports.ResultsDuring phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs 8.6% [31 of 360], P < .001). Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower phase 2 success rates while taking buprenorphine-naloxone.ConclusionsPrescription opioid-dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment; if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM.

Dataset Information

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

Publications

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets