Starting Treatment With Agonist Replacement Therapies (START)

Completed · Phase 4

Conditions studied: Opiate-related Disorders

In brief

The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.

Key facts

Study ID

NCT00315341

Run by

University of California, Los Angeles

People needed

1269

Starts

2006-04-01

Expected to finish

2010-08-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Were age 18 years or older,
• Met DSM-IV-TR criteria for opioid dependence,
• Were in good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, were under the care of a physician willing to continue participant's medical management and cooperate with study physicians,
• For female participants, use of one of the following acceptable methods of birth control:
• oral contraceptives
• barrier (diaphragm or condom) with spermicide
• IUD
• intrauterine progesterone contraceptive system
• levonorgestrel implant
• medroxyprogesterone acetate contraceptive injection
• contraceptive transdermal patch
• hormonal vaginal contraceptive ring
• surgical sterilization
• complete abstinence from sexual intercourse
• Able to read and verbalize understanding of the study and voluntarily sign study informed consent form.

You may not qualify if…

• ALT or AST values > 5 times the upper limit of normal as per testing laboratory range criteria,
• ALP values >3 times the upper limit of normal per testing laboratory criteria,
• Any documented past or present history of ascites, presence of esophageal or gastric varices, hepatic encephalopathy or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of ≥11,
• Total bilirubin > 2.0 mg/dl (participants with documented Gilbert's syndrome were not excluded based on this criterion),
• Prothrombin time more than 3 seconds prolonged,
• Albumin level less than 2.5 g/dl,
• Any cardiopathy or risk factor listed below without evidence of a normal ECG* with report performed within 6 months prior to first study medication dose,
• Congestive heart failure
• Left ventricular hypertrophy
• Bradycardia
• Hereditary QT prolongation
• Uncorrected electrolyte imbalance
• Concomitant medications that are known to have a risk of QT interval prolongation; refer to Appendix D for a list of medications.
• Note: The list was not all-inclusive.
• An ECG was abnormal if one or more of the following occurred:
• Significant ST segment abnormalities:
• ST segment elevations in two or more continuous leads of > 0.1 mV
• ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point ST segment abnormalities identified as "non-specific" are acceptable. If a potential participant's ECG indicated ST segment elevations or depression consistent with ischemia, the physician obtained a medical history of cardiac symptoms and referred the participant for evaluation.
• Conduction abnormalities:
• Mobitz II 2nd degree or 3rd degree heart block
• Atrial fibrillation, atrial flutter, or any non-sinus tachyarrhythmia
• Three or more consecutive ectopic ventricular complexes at a rate of > 100 per minute.
• QTc greater than 450 msec in men and 480 msec in women
• Repolarization abnormalities:
• Acute medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., unstable pancreatic, cardiovascular or renal disease, significant anemia)

Where it is running

• Matrix Institute — Los Angeles, California, United States
• Bi-Valley Medical Clinic INC. — Sacramento, California, United States
• BAART; Turk Street Clinic — San Francisco, California, United States
• Hartford Dispensary — Hartford, Connecticut, United States
• CT Counseling Centers — Waterbury, Connecticut, United States
• Addiction Research & Treatment Corp — Brooklyn, New York, United States
• CODA-Research — Portland, Oregon, United States
• NET Steps — Philadelphia, Pennsylvania, United States
• Evergreen Treatment Services — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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