ID

45763

Description

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.

Lien

dbGaP-study=phs001135

Mots-clés

  1. 16/06/2023 16/06/2023 - Chiara Middel
Détendeur de droits

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

Téléchargé le

16 juin 2023

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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dbGaP phs001135 Starting Treatment with Agonist Replacement Therapies (START)

Eligibility Criteria

Inclusion and exclusion criteria
Description

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.
Description

Elig.phs001135.v2.p1.1

Type de données

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

Similar models

Eligibility Criteria

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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