- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00218569
Combined Treatment for Cocaine-Alcohol Dependence - 1
25. januar 2016 opdateret af: Joy Schmitz, The University of Texas Health Science Center, Houston
Combined Treatment for Cocaine-Alcohol Dependence
The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence.
Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP).
Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits.
Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions.
CMP will be based on cocaine-negative urine screens and negative breath alcohol tests.
Follow-up assessments will be conducted at 3 and 6 months after treatment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
87
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas Health Sci Cntr Houston
-
-
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 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Give informed consent
- Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
- Be between 18 and 60 years old
- Meet DSM-IV criteria for both current cocaine and alcohol dependence
- Be in acceptable health based on physical exam, lab tests, and EKG
- Have a stable living situation and the availability of at least two locators
- Be able to read and write English at the 6th grade level
- Provide a least one cocaine positive urine during intake
- If female, must agree to use contraception
Exclusion Criteria:
- History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
- Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
- Abnormal liver function test results (both ALT and AST >3x upper limit normal or either >5x upper limit normal)
- Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
- Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
- Participating in 12 step meetings more than twice weekly
- Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
- Current dependence on any psychoactive disorder other than nicotine
- Impending incarceration
- Condition of probation or parole requiring reports of drug use to officers of the court
- Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
- Plans to move from the Houston area within the next three months
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: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 2
Placebo
|
Placebo
|
|
Eksperimentel: 1
Naltrexon
|
Naltrexone
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Urine toxicology for cocaine
Tidsramme: 12 weeks of study
|
12 weeks of study
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joy Schmitz, Ph.D., The University of Texas Health Science Center, Houston
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. april 2003
Primær færdiggørelse (Faktiske)
1. december 2007
Studieafslutning (Faktiske)
1. december 2007
Datoer for studieregistrering
Først indsendt
20. september 2005
Først indsendt, der opfyldte QC-kriterier
20. september 2005
Først opslået (Skøn)
22. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIDA-15801-1
- R01DA015801 (U.S. NIH-bevilling/kontrakt)
- R01-15801-1
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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