Factors Affecting Methamphetamine and Opiates Drug Testing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01736332|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : December 17, 2019
- 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.
- 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.
- Healthy volunteers between 18 and 65 years of age.
- 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....
|Condition or disease||Intervention/treatment||Phase|
|Opiates Healthy||Drug: Vicks VapoInhaler Other: Poppy seeds||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evidence-Based Drug Policy and Legislation: Amphetamines and Opiates in Blood, Oral Fluid and Urine Following Intranasal l-Methamphetamine and Oral Poppy Seeds|
|Study Start Date :||July 19, 2012|
|Actual Primary Completion Date :||January 31, 2014|
|Actual Study Completion Date :||January 31, 2014|
- Drug: Vicks VapoInhaler
2 inhalations each nostril every 2 hours for 6 doses on day 1, one dose on morning of day 2
- Other: Poppy seeds
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736332
|United States, Maryland|
|National Institute on Drug Abuse|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Marilyn Huestis, Ph.D.||National Institute on Drug Abuse (NIDA)|