The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
16
matching placebo
25mg bid/day (NX) 200mg bid/day (BUP)
Langley Porter Psychiatric Institute
San Francisco, California, United States
Cardiovascular System Effects
Heart rate, blood pressure, ECGs,and monitoring adverse events
Time frame: daily during the 10 day treatment period
Number of subjects with adverse events
Time frame: Day 0 through Day 10
Plasma concentrations obtained at specific timepoints
* PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure * PK of bupropion, naltrexone and their metabolites
Time frame: daily during the 10 day treatment period
Assessment of Vital Signs and Clinical Chemistries
Respiration rate and clinical laboratory measures
Time frame: Daily during the 10 day treatment period
Cognitive Assessments as reported by the subject
Subject reported effects measured with VAS, BSCS, and POMS
Time frame: Dailly during the 10 day treatment period
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