- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01140334
Treatment for Psychological and Drug Abuse Problems
19. september 2013 opdateret af: Michael Kidorf, Johns Hopkins University
Maximizing Effectiveness of Integrated Treatment Approaches
The purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care.
Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist.
Patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives.
These incentives can be earned by successfully attending all scheduled psychiatric appointments each week.
The investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Male and female opioid-dependent patients at Addiction Treatment Services with any current psychiatric disorder (N = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (ROIC), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (SOIC).
Participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services.
Participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention.
Positive findings would have considerable heuristic and health care policy and practice implications.
The entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
158
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Addiction Treatment Services
-
-
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
Inclusion Criteria:
- At least 18 years of age
- Voluntarily seeking psychiatric treatment
- Meets DSM-IV criteria for opiate dependence
- Meets FDA/CSAT guidelines for methadone maintenance
- Meets DSM-IV criteria for at least one current psychiatric disorder
Exclusion Criteria:
- Pregnancy
- Onset or acute exacerbation of a medical illness requiring immediate and intense care
- An organic mental disorder (e.g., delirium, dementia)
- Current participation in psychiatric care
- Mandatory psychiatric treatment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Reinforced On-Site Integrated Care (ROIC)
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance.
|
Patients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions.
These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments.
Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant.
The maximum amount of voucher earnings over the study is $300.
|
Aktiv komparator: Standard On-Site Integrated Care (SOIC).
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
|
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
No voucher incentive will be offered in this condition.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Psychiatric Treatment Adherence
Tidsramme: Weekly for 12 weeks
|
Patient adherence to all scheduled psychiatric sessions (i.e.
individual, group, psychiatrist) will be measured weekly for 12 weeks.
|
Weekly for 12 weeks
|
Level of Psychiatric Distress
Tidsramme: Every 4-weeks for 12 weeks
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Patients will complete the Addiction Severity Index (ASI) and the SCL-90 every 4-weeks, for 12-weeks, to measure their current levels of psychiatric distress.
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Every 4-weeks for 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Psychiatric Medication Adherence
Tidsramme: Every 4-weeks
|
Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.
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Every 4-weeks
|
Substance Use
Tidsramme: Weekly for 12-weeks
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Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).
|
Weekly for 12-weeks
|
Treatment Retention
Tidsramme: Weekly for 12-weeks
|
The length of time subjects remain in treatment is tracked throughout the study.
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Weekly for 12-weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Kidorf, Ph.D., Johns Hopkins University
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
1. december 2009
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
3. juni 2010
Først indsendt, der opfyldte QC-kriterier
8. juni 2010
Først opslået (Skøn)
9. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. september 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2013
Sidst verificeret
1. september 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1RC1DA028154-01 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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