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A SMART Design for Attendance-based Prize CM

5. april 2019 opdateret af: UConn Health
The purpose of this study is to compare different forms of treatment for substance abuse. This study will involve a type of treatment called contingency management, in which patients receive incentives (prizes) for attending outpatient treatment. This study will compare contingency management to standard treatment that does not involve incentives. This study will also compare contingency management treatment that lasts 6 weeks to contingency management that lasts 12 weeks. Finally, this study will compare contingency management treatment delivered at the beginning of outpatient treatment to contingency management treatment delivered later during outpatient treatment. The investigators hypothesize that (1) a 12-week attendance-based contingency management intervention will improve retention and enhance drug abstinence versus standard treatment, (2) initial short-term exposure to attendance-based contingency management (in weeks 1-6 only) will improve substance abuse treatment outcomes compared to standard treatment alone, and (3) contingency management in weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug use during initial stages of treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

360

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
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • University of Connecticut Health Center

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:

  • age > 18 years
  • current DSM-IV diagnosis of cocaine abuse or dependence or recent cocaine use (self-reported use in past 30 days or positive urine toxicology screen)
  • willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
  • in recovery from pathological gambling (meet DSM-IV criteria for lifetime pathological gambling and are actively trying to refrain from gambling)
  • do not speak English (all treatment is provided in English at these clinics)

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: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Treatment Group A
Individuals randomized to Treatment Group A will receive standard treatment for study weeks 1-6.
Eksperimentel: Treatment Group B
Individuals randomized to Treatment Group B will receive contingency management plus standard treatment for study weeks 1-6.
Adfærdsmæssigt: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.
Ingen indgriben: Aftercare Group A
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group A will receive standard treatment for study weeks 7-12.
Eksperimentel: Aftercare Group B
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group B will receive contingency management treatment plus standard treatment for weeks 7-12.
Adfærdsmæssigt: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
longest duration of negative drug and alcohol samples submitted
Tidsramme: throughout active phase and at each follow-up assessment
throughout active phase and at each follow-up assessment

Sekundære resultatmål

Resultatmål
Tidsramme
proportions of samples testing negative for drugs and alcohol
Tidsramme: during active phase and at each follow-up assessment
during active phase and at each follow-up assessment
psychosocial functioning and HIV risk behaviors
Tidsramme: baseline, active phase and at each follow-up assessment
baseline, active phase and at each follow-up assessment

Samarbejdspartnere og efterforskere

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

Sponsor

UConn Health

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Nancy M Petry, Ph.D., UConn Health

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. januar 2009

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

7. februar 2009

Først indsendt, der opfyldte QC-kriterier

9. februar 2009

Først opslået (Skøn)

10. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09-053-2
  • P50DA009241-16 (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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