Computer-based psychoeducational intervention og community-based substance abuse counseling i Adult Opioid-Dependence - Kliniske forsøgsregister

Studieoversigt

Status

Ukendt

Betingelser

Adult Opioid-Dependence

Intervention / Behandling

Detaljeret beskrivelse

The partial opioid agonist, buprenorphine, was recently approved by the FDA for the treatment of opioid-dependence and will be available via physician prescription, enabling a greatly needed expansion of access to opioid treatment services. However, physicians, because of considerable demands on their time, will likely be unable to provide or coordinate referral for opioid-dependent patients to receive supplemental educational interventions that are critical to the success of their treatment. To address this challenge, we are developing an interactive, web-based patient education system for opioid-dependent individuals in office-based buprenorphine treatment. In this system, we plan to provide patients with educational interventions of demonstrated efficacy (e.g., information about buprenorphine, HIV/AIDS education, relapse prevention skills training). In Phase I, we demonstrated the scientific, technical and commercial merit and feasibility of this web-based patient education system by developing several modules of the program as well as the appropriate technology for the program to be delivered in an office-based setting. We subsequently assessed these modules in the context of feedback sessions conducted with opioid-dependent individuals in a lab designed to mimic the technical constraints of a physician's office. Results demonstrated that this system represents a viable approach to patient education in office-based buprenorphine treatment. During Phase II, we plan to complete our research and development efforts on this project. We will complete all educational modules of the system. We will also develop a "customization program" that patients can use to help them identify the optimal order in which they may access the program modules while in treatment. Additionally, we will establish an electronic reporting system that will provide physicians prescribing buprenorphine with patient activity reports, enabling them to track and document patient progress through the system and ensure that patients are compliant with ancillary educational interventions. Additionally, we plan to conduct a randomized, controlled trial to evaluate the efficacy and cost-effectiveness of this patient education system delivered via the Internet compared to the delivery of patient educational services by community-based treatment facilities outside of the office-based setting. This system will provide patients, physicians and the larger community with assurance that patients in office-based buprenorphine treatment are receiving ancillary services along with their medication, thereby improving their likelihood for a successful treatment outcome.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- New York
  - New York, New York, Forenede Stater, 10011
    - Rekruttering
    - Dr. Steven Lee
    - Ledende efterforsker:
      
      Lisa Marsch, PhD
    - Kontakt:
      
      Honoria Guarino, PhD
      
      Telefonnummer: 212-845-4540
      
      E-mail: guarino@ndri.org
    - Kontakt:
      
      Lisa Marsch, PhD
      
      Telefonnummer: 212-845-4655
      
      E-mail: marsch@ndri.org
  - New York, New York, Forenede Stater, 10023
    - Rekruttering
    - Dr. Tania Taubes
    - Ledende efterforsker:
      
      Lisa Marsch, PhD
    - Kontakt:
      
      Lisa Marsch, PhD
      
      Telefonnummer: 212-845-4655
      
      E-mail: marsch@ndri.org
    - Kontakt:
      
      Honoria Guarino, PhD
      
      Telefonnummer: 212-845-4540
      
      E-mail: guarino@nri.org

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Opioid dependence
Adults ( >/= 18 years)
In first month of office-based buprenorphine maintenance treatment

Exclusion Criteria:

In buprenorphine-assisted taper

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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
opiatbrug

Sekundære resultatmål

Resultatmål
HIV-risikoadfærd
feedback på intervention
behandlingsfastholdelse
andet stofbrug
opiat trang
psychosocial status

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Development and Research Institutes, Inc.

Efterforskere

Ledende efterforsker: Lisa Marsch, PhD, National Development and Research Institutes, Inc.

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 2004

Datoer for studieregistrering

Først indsendt

10. september 2005

Først indsendt, der opfyldte QC-kriterier