Buprenorfine voor proefpersonen en parolees: overbrugging van de kloof in behandeling
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Project implementation will occur at Guilford Avenue, the primary intake unit for Baltimore City Community Supervision (Probation and Parole). The proposed study is a parallel two-group randomized controlled trial in which 160 men and 160 women with OUD on community supervision in Baltimore will be randomly assigned within community supervision status (probation or parole) and gender to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid drug test (oral saliva) results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of probationers/parolees with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21202
- Division of Parole & Probation
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subject must provide written informed consent prior to the conduct of any study-related procedures
- Male or female, 18-65 years of age, inclusive
- Be on parole or probation for at least the next 4 months
- Have a Baltimore City address, and (5) Primary diagnosis of (DSM-5) moderate-severe opioid use disorder (at least 4 symptoms) including current use and current physiologic dependence [Note: parolees not currently physically dependent will be allowed in the study].
Exclusion Criteria:
- Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation
- Current psychosis or suicidal ideation
- Cognitive disorders that prevent the participant from passing a study enrollment quiz
- Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)
- Exposure to any investigational drug within 8 weeks of screening
- Current use benzodiazepines (such as Valium, Xanax and other sedatives), either prescribed or illicitly obtained
- Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: TAU
Participants will receive a referral to buprenorphine treatment in the community. |
Participants will receive a referral to buprenorphine treatment in the community
Andere namen:
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Experimenteel: BBT
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment |
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
opioid use
Tijdsspanne: 12 months
|
illicit opioid drug test (oral saliva) results |
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
treatment adherence
Tijdsspanne: 12 months
|
entered community based treatment |
12 months
|
|
treatment adherence
Tijdsspanne: 12 months
|
number of days receiving opioid treatment |
12 months
|
|
opioid use days
Tijdsspanne: 12 months
|
number of days using illicit opioids |
12 months
|
|
health-related quality of life
Tijdsspanne: 12 months
|
physical health using the SF-12 Health Survey |
12 months
|
|
health-related quality of life
Tijdsspanne: 12 months
|
mental health using the SF-12 Health Survey |
12 months
|
|
HIV risk behaviors
Tijdsspanne: 12 months
|
sexual behavior using the Risk Assessment Battery (RAB) |
12 months
|
|
HIV risk behaviors
Tijdsspanne: 12 months
|
needle use or sharing using the Risk Assessment Battery (RB) |
12 months
|
|
criminal activity
Tijdsspanne: 12 months
|
criminal activity days |
12 months
|
|
re-arrest
Tijdsspanne: 12 months
|
time to re-arrest |
12 months
|
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re-incarceration
Tijdsspanne: 12 months
|
time to re-incarceration |
12 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Heterocyclische verbindingen
- Heterocyclische verbindingen, gefuseerd ring
- Farmaceutische voorbereidingen
- Alkaloïden
- Polycyclische aromatische koolwaterstoffen
- Polycyclische verbindingen
- Heterocyclische verbindingen, 4 of meer ringen
- Drugscombinaties
- Naloxon
- Morphinans
- Opiaat alkaloïden
- Heterocyclische verbindingen, overbrugde ring
- Fenanthrenes
- Buprenorfine
- Buprenorfine, Naloxon Geneesmiddelencombinatie
- Therapeutica
Andere studie-ID-nummers
- FRI
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
FRI is committed to the open and timely dissemination of research outcomes. Investigators in the proposed activity recognize that promising new methods and strategies may arise during the course of the research. Fri will abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Working with the research community, as well as the federal funding agency, FRI will serve the scientific community at large by sharing ideas and software to ensure that new knowledge benefits society. Our goals are to disseminate new ideas so the public can benefit from discoveries, and to generate new ideas for research and education. Any data shared will be de-identified and follow the regulations set forth in applicable Human Subjects Protection Guidelines.
IPD-tijdsbestek voor delen
At completion of the study.
IPD-toegangscriteria voor delen
Contact Dr. Michael Gordon Friends Research Institute
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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