- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00675532
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
Status
Trukket tilbage
Betingelser
Intervention / Behandling
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Yale HIC #0708002942
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
-
Theravance BiopharmaAfsluttet
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Drug-Drug Interaction (DDI)Det Forenede Kongerige
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Drug-Drug Interaction (DDI)Frankrig
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Astellas Pharma Europe B.V.Medivation, Inc.AfsluttetSunde emner | Drug-Drug Interaction (DDI) | Enzalutamids farmakokinetikTyskland
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | DDI (Drug-Drug Interaction)Tyskland
-
The Netherlands Cancer InstituteIkke rekrutterer endnuDrug Adherence Marker
-
Washington State UniversityNational Center for Complementary and Integrative Health (NCCIH)AfsluttetInteraktion Drug FoodForenede Stater
-
Astellas Pharma Europe B.V.Cubist Pharmaceuticals LLCAfsluttetSunde emner | Drug-Drug Interaction (DDI) | Intestinal Absorption | Farmakokinetik af Rosuvastatin | Farmakokinetik af fidaxomicinTyskland
Kliniske forsøg med Primary Care Counseling
-
Stryker Trauma GmbHRekrutteringRotator Cuff River | Skulderdeformitet | Slidgigt Skulder | Avaskulær nekrose af Humerus-hovedet | Reumatoid Arthritis Skulder | Brud, Humerus | Traumatisk arthritis i højre skulderregion (diagnose)Forenede Stater
-
Northwestern UniversityGeorgetown UniversityTilmelding efter invitationKroniske nyresygdomme | Genetisk dispositionForenede Stater
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbejdspartnereRekruttering
-
Texas Christian UniversityAfsluttetMapping Enhanced Counseling (MEC) | Active Linkage (AL)Forenede Stater
-
Second Affiliated Hospital, School of Medicine,...Zhejiang University; First Affiliated Hospital of Wenzhou Medical University og andre samarbejdspartnereLedigST Elevation MyokardieinfarktKina
-
Midwest Evaluation & ResearchAnthem Strong FamiliesRekruttering
-
Kaiser PermanenteIkke rekrutterer endnuOpmærksomhedsunderskud hyperaktivitetForenede Stater
-
Stryker OrthopaedicsAktiv, ikke rekrutterende
-
Fundacion para la Investigacion y Formacion en...AfsluttetULTRASONOGRAFI | PRIMÆRE SUNDHEDSSEKTORSpanien
-
Thomas Jefferson UniversityIndependence Blue CrossAktiv, ikke rekrutterendeAlzheimers sygdom | Frontotemporal degeneration | Vaskulær demens | Demens af Alzheimer-typen | Lewy Body Demens | Blandet demens | Vaskulær kognitiv svækkelseForenede Stater