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Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

19. juli 2013 opdateret af: David Fiellin, Yale University
In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.

Studieoversigt

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale New Haven Hospital Primary Care 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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female individuals, ages 18 and above, meeting current diagnostic and statistical manual (DSM-IV) criteria for opioid dependence.
  • Subject has voluntarily given informed consent and signed the informed consent document.
  • Able to read English and complete study evaluations.

Exclusion Criteria:

  • Regular use of benzodiazepines.
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
  • Abstinent from opiates for more than four weeks prior to naltrexone initiation.
  • Medical problems that would preclude naltrexone treatment, such as laboratory evidence of significant hepato-cellular injury as evidenced by abnormal liver enzyme tests including SGOT and SGPT (> three times normal) or elevated bilirubin levels), and a history of cirrhosis.
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial evaluation for naltrexone, and every two weeks during the course of the study).

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
Eksperimentel: 1
Primary Care Counseling
Subjects in this condition will attend bi-weekly 15 minute sessions with the study nurse for primary care counseling which is a brief manual-guided, medically focused counseling approach to the treatment of opioid dependent individuals seen in primary care settings. The brief counseling sessions involve repeated support for and monitoring of medication compliance, and the provision of advice regarding established methods for coping with psychological and social factors that lead to drug use.
Eksperimentel: 2
Cognitive-behavioral psychotherapy (CBT)
Subjects in the CBT condition will participate in bi-weekly 50-minute-long individualized cognitive-behavioral psychotherapy sessions with a CBT trained clinician. The general purpose of the therapy is to: (1) acquire information about important concepts and aspects of recovery from opioid addiction; (2) increase self-awareness of specific problems and issues in relation to addiction and recovery, and (3) learn new coping skills to deal with problems contributing to or resulting from the addiction and to improve overall psychosocial functioning. The primary focus of this approach is to provide patients with frequent supportive contact and to teach cognitive-behavioral relapse prevention skills.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment.
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction.
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: David Fiellin, Ph.D., Yale School of Medicine

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. maj 2011

Primær færdiggørelse (Forventet)

1. maj 2013

Studieafslutning (Forventet)

1. august 2013

Datoer for studieregistrering

Først indsendt

7. maj 2008

Først indsendt, der opfyldte QC-kriterier

7. maj 2008

Først opslået (Skøn)

9. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Narkotikaafhængighed

Kliniske forsøg med Primary Care Counseling

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Abonner