A Phase 1 interventional study of Vicks VapoInhaler and Poppy seeds in Opiates and Healthy, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Diagnostic
Background:
Objectives:
Eligibility:
Design:
Objective: Two widely available legal products, Vicks VapoInhaler (lmethamphetamine with trace amounts of d-methamphetamine) and poppy seeds (morphine and codeine) contain small amounts of psychoactive substances that may generate positive tests for regulated drugs conducted in forensic, workplace and drug abuse treatment settings. This study evaluates the prevalence and duration of positive amphetamines and opiates drug tests in blood, oral fluid (OF) and urine.
Study population: Up to 30 healthy adults without a history of clinically significant adverse reactions to nasal or oral decongestants or stimulants, to oral opiates, or to poppy seeds, buckwheat, hazelnuts, or sesame.
Design: This is an open-label, non-treatment study in which each participant spends two days at NIDA IRP and the intervening night on the Behavioral Pharmacology Research Unit (BPRU). Vicks VapoInhaler (0.16-0.60 milligrams of l-methamphetamine and trace amounts of d-methamphetamine) is administered intranasally every two hours for six doses from 9 am to 7 pm on the first day and a seventh dose at 6 am the second day. Food grade uncooked poppy seeds (45 grams suspended in 500 milliliter of liquid) are administered orally at 9 am and 5 pm on the first day only.
Outcome measures: The primary outcome measures are prevalence of positive tests and windows of drug detection (based on concentrations in the biological matrix) of methamphetamine, l-amphetamine, morphine, and codeine in blood, OF, and urine. Secondary outcome measures are 1) performance of 2 OF collection devices (Quantisal and Oral-Eze) and an on-site OF screening test (Draeger Drug Test 5000) in comparison to liquid chromatography-tandem mass spectrometry (LCMSMS), and performance of urine screening test in comparison to gas chromatography-mass spectrometry (GC-MS). Performance parameters are prevalence of positive tests at each time point, windows of drug detection, sensitivity, and specificity for l-methamphetamine, l-amphetamine, morphine, and codeine in OF and urine. Cutoff concentrations for each matrix are those specified in the Mandatory Guidelines for Federal Workplace Drug Testing Programs; 2) detection of d-methamphetamine in any blood, OF and urine specimen; and 3) time course of these analytes in blood for comparison to other matrices, especially oral fluid/blood ratios.
Significance: These data are essential for establishing evidence-based drug policy and legislation, for establishing oral fluid drug testing by the Substance Abuse and Mental Health Services Administration, and for answering current questions about whether use of these legal products could produce positive tests in federally mandated drug testing programs.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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EXCLUSION CRITERIA:
degree A-V block, acute coronary syndrome, premature atrial contractions occurring more than 3/min, or premature ventricular contractions occurring more than 1/min.
2 inhalations each nostril every 2 hours for 6 doses on day 1, one dose on morning of day 2
45 g in liquid at 9 am and 5 pm on day 1
Prevalence of positive tests and windows of drug detection (based on concentrations in the biological matrix) of I-methamphetamine, I-amphetamine, morphine, and codeine in blood, OF, and urine.
Heart rates, blood pressure, respiratory rate
Time frame: 30 hours
Performance of 2 OF collection devices (Quantisal and Oral-Eze) and an on-site OF screening test (Draeger Drug Test 5000) in comparison to LC-MS-MS and performance fo urine screening test in comparison to GC-MS.
Time frame: 2 years
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)