Factors Affecting Methamphetamine and Opiates Drug Testing
Condition: Opiates; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as
      poppy seeds) may cause a positive screening drug test. This might look like someone used
      illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are
      studying how the body handles chemicals that may test like illegal drugs and for how long
      they may be detected in the body. Blood, saliva, and urine samples will be collected. This
      study may help improve the effectiveness and accuracy of drug tests.

      Objectives:

      - To see how the body handles chemicals that may produce positive screening tests and how
      additional testing can eliminate positive drug tests from over-the-counter drugs and food.

      Eligibility:

      - Healthy volunteers between 18 and 65 years of age.

      Design:

        -  Participants are screened with a physical exam, medical history, laboratory tests, and
           ECG.

        -  This study involves an overnight stay on a secure research unit and 2 days of tests.

        -  On the first day, participants will take Vicks VapoInhaler (two inhalations in each
           nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing
           poppy seeds twice (at about 9 a.m. and 5 p.m.).

        -  On the morning of the second day, participants will take the Vicks VapoInhaler just
           once. They will be discharged around 5 p.m.

        -  On both days, participants will provide blood and saliva samples several times
           throughout the day. All of their urine will be collected during the 2 study days....
    

Detailed description: 
      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.
    

Intervention name(s): Vicks VapoInhaler; Poppy seeds
Intervention type(s): Drug; Other
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Methamphetamine; Amphetamines; Opiates; Oral Opiates (poppy seeds); Intranasal amphetamines