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OpiatesPhase 1NCT01736332

Factors Affecting Methamphetamine and Opiates Drug Testing

A Phase 1 study testing Vicks VapoInhaler and Poppy seeds in people with Opiates and Healthy, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Opiates, Healthy
What is being tested?
Vicks VapoInhaler and Poppy seeds
How many people
29 participants
Where
1 siteUnited States
Study dates
19 Jul 2012to 31 Jan 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years.
  • Able to give valid informed consent.
  • Able to cooperate with all study procedures.
  • Peripheral venous access adequate to allow repeated blood sampling

Who cannot join

  • Current medical condition that precludes safe study participation, such as 2nd or 3rd
  • Current physical dependence on any psychoactive substance other than caffeine or nicotine.
  • degree A-V block, acute coronary syndrome, premature atrial contractions occurring more than 3/min, or premature ventricular contractions occurring more than 1/min.
  • Inability to tolerate intranasal medication administration.
  • Inability to safely swallow liquids containing poppy seeds.
  • History of clinically significant adverse reaction to intranasal or oral decongestants.
Show all 18Show fewer
  • History of clinically significant adverse reaction to opiates.
  • History of clinically significant adverse reaction from exposure (oral, inhalational, tactile) to poppy seeds, buckwheat, hazelnuts, or sesame.
  • Inability to tolerate abstinence from any medication that might adversely interact with opiates, e.g., CNS depressant, systemically acting anti-cholinergic, or monoamine oxidase inhibitor.
  • Women who are pregnant or nursing.
  • Use, within 7 days of initial dosing with study substances, of prescription amphetamine or opiate-like substances that are related to the substances being tested.
  • Internal nasal lesions that increase risk of inhalation of Vicks VaporInhaler
  • Current hypertension, cardiomyopathy,or other current medical conditions associated with increased risk from adrenergic or opioid drug administration.
  • Resting blood pressure consistently >140/90 mm Hg or heart rate consistently > 90 bpm
  • Resting systolic blood pressure consistently < 90
  • Urine drug test positive for amphetamines or opiates
  • Use of a nasal decongestant or ingested an amphetamine, opiate, CNS depressant, anticholinergic, or poppy seeds within the prior week, or a monoamine oxidase inhibitor within the prior 2 weeks
  • History of psychosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institute on Drug Abuse

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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

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.
Read more

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....
Read the 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.

Conditions
Opiates, Healthy
Being tested
Vicks VapoInhaler, Poppy seeds
Keywords
Methamphetamine, Amphetamines, Opiates, Oral Opiates (poppy seeds), Intranasal amphetamines

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vicks VapoInhalerDrug

    2 inhalations each nostril every 2 hours for 6 doses on day 1, one dose on morning of day 2

  • Poppy seedsOther

    45 g in liquid at 9 am and 5 pm on day 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

Secondary outcomes (2)

  1. Heart rates, blood pressure, respiratory rate

    Measured: 30 hours

  2. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start19 Jul 2012
  3. Primary completion31 Jan 2014
  4. Study completion31 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736332
Sponsor's protocol ID
999912481
Other IDs
12-DA-N481
Status last verified
19 Mar 2014
First submitted
27 Nov 2012
Last updated
17 Dec 2019
Results posted
No

Publications

  • Crivellaro M, Bonadonna P, Dama A, Senna GE, Mezzelani P, Mistrello G, Passalacqua G. Severe systemic reactions caused by poppy seed. J Investig Allergol Clin Immunol. 1999 Jan-Feb;9(1):58-9.

    PubMed 10212860

  • Dufka F, Galloway G, Baggott M, Mendelson J. The effects of inhaled L-methamphetamine on athletic performance while riding a stationary bike: a randomised placebo-controlled trial. Br J Sports Med. 2009 Oct;43(11):832-5. doi: 10.1136/bjsm.2008.048348. Epub 2008 Nov 3.

    PubMed 18981044

  • Fritschi G, Prescott WR Jr. Morphine levels in urine subsequent to poppy seed consumption. Forensic Sci Int. 1985 Feb;27(2):111-7. doi: 10.1016/0379-0738(85)90173-2.

    PubMed 3979930

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vicks VapoInhaler and Poppy seeds in people with Opiates and Healthy, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736332, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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