ID

45763

Beschreibung

Principal Investigator: Wade H. Berrettini, MD, PhD, University of Pennsylvania MeSH: Opioid-Related Disorders,Substance-Related Disorders https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001135 The Starting Treatment with Agonist Replacement Therapy (START) study was a 24-week, open-label, randomized trial of methadone *versus* Suboxone (buprenorphine/naloxone) for the treatment of opioid dependence. Patients were over the age of 18 and met DSM-IV qualifications for opioid dependence. The primary goal of the study was to determine if either medicine was associated with liver toxicity issues in this vulnerable patient population. Liver enzymes were measured at four time points. Urinalysis for opioids, cocaine, cannabis, benzodiazepines, and methamphetamine were performed on a weekly basis. A flexible dosing scheme was used during which physicians could alter medication dose based on withdrawal symptoms and urinalysis results. Neither medication was found to be associated with liver enzyme levels. In version 2 of this study, a text file containing 7704 SNPs with large allele frequency discrepancy as compared to 1000 Genomes is included. Users have the option to exlude these 7704 SNPs.

Link

dbGaP-study=phs001135

Stichworte

  1. 16.06.23 16.06.23 - Chiara Middel
Rechteinhaber

Wade H. Berrettini, MD, PhD, University of Pennsylvania

Hochgeladen am

16. Juni 2023

DOI

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Lizenz

Creative Commons BY 4.0

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dbGaP phs001135 Starting Treatment with Agonist Replacement Therapies (START)

Eligibility Criteria

Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Individuals were *included* if they met DSM-IV-TR criteria for opioid dependence and were at least 18 years of age. Individuals were *excluded* from the trial for any of the following reasons: cardiomyopathy, liver disease, acute psychosis, blood levels of alanine amino transferase or aspartate amino transferase greater than five times the maximum normal level, or poor venous access.
Beschreibung

Elig.phs001135.v2.p1.1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0220952
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0242402
UMLS CUI [1,5]
C0038580
UMLS CUI [1,6]
C0001779
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0878544
UMLS CUI [2,3]
C0023895
UMLS CUI [2,4]
C0281774
UMLS CUI [2,5]
C0151905
UMLS CUI [2,6]
C0151904
UMLS CUI [2,7]
C4489703
UMLS CUI [2,8]
C0542537

Ähnliche Modelle

Eligibility Criteria

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001135.v2.p1.1
Item
Individuals were *included* if they met DSM-IV-TR criteria for opioid dependence and were at least 18 years of age. Individuals were *excluded* from the trial for any of the following reasons: cardiomyopathy, liver disease, acute psychosis, blood levels of alanine amino transferase or aspartate amino transferase greater than five times the maximum normal level, or poor venous access.
boolean
C1512693 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0242402 (UMLS CUI [1,4])
C0038580 (UMLS CUI [1,5])
C0001779 (UMLS CUI [1,6])
C0680251 (UMLS CUI [2,1])
C0878544 (UMLS CUI [2,2])
C0023895 (UMLS CUI [2,3])
C0281774 (UMLS CUI [2,4])
C0151905 (UMLS CUI [2,5])
C0151904 (UMLS CUI [2,6])
C4489703 (UMLS CUI [2,7])
C0542537 (UMLS CUI [2,8])

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