Employment-Based Depot Naltrexone Clinical Trial II
27. december 2017 opdateret af: Johns Hopkins University
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults.
Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used.
Participants will be offered an inpatient opioid detoxification and oral naltrexone induction.
Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups.
Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months.
Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections once per month.
"Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21224
- The Center for Learning and Health
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Individuals were eligible if they:
- met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,
- reported using heroin at least 21 of the last 30 days while living in the community,
- were unemployed,
- were 18-65 years old,
- were medically approved for naltrexone,
- lived in or near Baltimore, MD.
Individuals were excluded if they:
- were pregnant or breastfeeding,
- had serum aminotransferase levels over three times normal,
- had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
- expressed interest in methadone treatment,
- were required to use opioids for medical purposes,
- earned over $200 in taxable income over the previous 30 days,
- had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Work Plus Naltrexone Prescription
Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
|
|
|
Eksperimentel: Work Plus Naltrexone Contingency
Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.
|
Vivitrol, an extended-release depot formulation of naltrexone, was used.
Participants were offered an inpatient opioid detoxification and oral naltrexone induction.
Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups.
Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months.
Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Naltrexone Injections Received
Tidsramme: 24 weeks
|
The percentage of depot naltrexone doses that participants received
|
24 weeks
|
|
Time to the First Missed Dose
Tidsramme: 24 weeks
|
The time to the first missed dose of depot naltrexone
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of 30-day Urine Samples Negative for Opiates
Tidsramme: Collected every 30 days for 150 days
|
Percentage of urine samples collected at the 30-day assessments that are negative for opiates
|
Collected every 30 days for 150 days
|
|
Percentage of M-W-F Samples Negative for Cocaine
Tidsramme: Collected every Monday, Wednesday and Friday for 24 weeks
|
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
|
Collected every Monday, Wednesday and Friday for 24 weeks
|
|
Average Percentage of 30-day Urine Samples Negative for Cocaine
Tidsramme: Collected every 30 days for 150 days
|
The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
|
Collected every 30 days for 150 days
|
|
HIV Risk Behaviors
Tidsramme: 24 weeks
|
behaviors that place participants at risk for acquiring or transmitting HIV infection
|
24 weeks
|
|
Percentage of M,W,F Urine Samples Negative for Opiates
Tidsramme: Collected every Monday, Wednesday and Friday for 24 weeks
|
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
|
Collected every Monday, Wednesday and Friday for 24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kenneth Silverman, Ph.D., Professor, Johns Hopkins University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2008
Primær færdiggørelse (Faktiske)
30. april 2010
Studieafslutning (Faktiske)
30. april 2010
Datoer for studieregistrering
Først indsendt
23. maj 2008
Først indsendt, der opfyldte QC-kriterier
23. maj 2008
Først opslået (Skøn)
28. maj 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. december 2017
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIDA-19497-2
- R01DA019497-02 (U.S. NIH-bevilling/kontrakt)
- NA_00000928 (Anden identifikator: Johns Hopkins Medicine IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
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Ingen
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