- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01560221
Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
10 december 2014 bijgewerkt door: Anthony DeFulio, Johns Hopkins University
The combination of using injection drugs, smoking crack cocaine, having multiple sex partners, and inconsistent condom use results in substantial risk for acquiring and transmitting HIV, and many drug dependent adults who have been arrested on charges of prostitution fit this profile.
Existing interventions for reducing HIV risk have had limited efficacy in drug-dependent sex workers, and criminal justice approaches have been ineffective despite their high cost.
A potentially ideal alternative is to divert drug-dependent arrestees from prosecution to a treatment that reduces drug use and HIV sex risk behaviors, while providing job skills training and promoting community employment to alleviate the financial need to continue sex work.
In order to provide an effective therapeutic alternative to criminal prosecution, the investigators propose to develop a multifaceted intervention that includes opiate agonist treatment (i.e., methadone OR buprenorphine) and the Therapeutic Workplace.
The Therapeutic Workplace is a supported environment in which participants are required to provide drug-free urine samples to access paid job skills training or employment and to maintain the maximum rate of pay.
The overall intervention is designed to reduce drug use and HIV risk behaviors, and simultaneously promote employment.
The proposed project is a 2-year Stage I behavior therapy development effort that will include the development, manualization and pilot testing of a Therapeutic Workplace intervention tailored to drug-dependent adults arrested for prostitution.
In the pilot study, the investigators will recruit opiate- and cocaine-dependent adults arrested for prostitution from the Eastside District Court in Baltimore.
Eligible individuals will be offered methadone treatment in lieu of prosecution and will be required to remain in methadone treatment for 90 days to have the charges against them dropped.
After enrolling in opiate agonist treatment, the diverted individuals will be invited to participate in the pilot study.
Interested individuals will be randomly assigned to receive the standard opiate agonist treatment services or these services plus the Therapeutic Workplace.
The Therapeutic Workplace has two phases.
In Phase 1, participants will be offered four months of stipend-supported job training in the Therapeutic Workplace.
In Phase 2, participants will be encouraged to seek employment in a community job and will receive wage subsidies for four months for maintaining community employment or engaging in supervised job seeking.
Throughout both phases, participants will be required to provide drug-free urine samples to receive Therapeutic Workplace wages (training stipends in Phase 1 and wage subsidies in Phase 2).
The wage subsidy program will include drug testing managed by a national supplier of drug-free workplace services.
Overall, this treatment could serve as a novel and ideal intervention for drug-dependent adults arrested for prostitution while reducing criminal justice costs.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
38
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21224
- The Center for Learning and Health
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion criteria:
- Opioid dependent
- Adults
- Recently arrested
- Have a pending charge of prostitution or perverted practice
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
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 |
|---|---|
|
Experimenteel: Therapeutic Workplace
Participants will receive all standard services plus the Therapeutic Workplace intervention, in which access to stipend supported training and/or wage subsidies for community employment is contingent upon drug abstinence as verified by urinalysis.
|
Participants can access stipend supported academic and job skills training for adults and/or receive wages or wage subsides for actual employment.
Access to training and employment is contingent upon meeting therapeutic targets.
Potential targets include, but are not limited to, drug abstinence and medication adherence.
Methadone in liquid form, with the dosage determined by physician on an individual basis.
Anticipated dose range 30mg to 100mg daily.
Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.
Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
Andere namen:
|
|
Actieve vergelijker: Standard Services
Participants will receive methadone treatment or buprenorphine treatment, depending upon medical recommendations of their physicians, slot availability, and their own preferences.
Participants who remain in treatment for at least 90 days will have the charge of prostitution that is pending against them dropped.
|
Methadone in liquid form, with the dosage determined by physician on an individual basis.
Anticipated dose range 30mg to 100mg daily.
Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.
Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Drug abstinence
Tijdsspanne: Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.
|
A combination of urinalysis and self-reports of illicit drug use.
This outcome is treated as dichotomous: Urine samples are considered positive or negative based on standard cutoffs for drugs of abuse, and self-reports are yes or no depending upon whether there was or was not any drug use in the previous 30 days.
|
Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
HIV Sex Risk
Tijdsspanne: Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.
|
The self-reported number of unprotected vaginal and anal sex occasions in the prior month.
|
Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anthony DeFulio, Ph.D., Johns Hopkins University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2012
Primaire voltooiing (Werkelijk)
1 december 2014
Studie voltooiing (Werkelijk)
1 december 2014
Studieregistratiedata
Eerst ingediend
15 maart 2012
Eerst ingediend dat voldeed aan de QC-criteria
21 maart 2012
Eerst geplaatst (Schatting)
22 maart 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
11 december 2014
Laatste update ingediend die voldeed aan QC-criteria
10 december 2014
Laatst geverifieerd
1 december 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Chemisch veroorzaakte aandoeningen
- Middelgerelateerde aandoeningen
- Fysiologische effecten van medicijnen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Pijnstillers, opioïden
- Verdovende middelen
- Narcotische antagonisten
- Agenten van het ademhalingssysteem
- Antitussiva
- Buprenorfine
- Methadon
Andere studie-ID-nummers
- R34DA033141 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .