Factors Affecting Methamphetamine and Opiates Drug Testing

NCT01736332 | Completed Phase 1

• 2 other identifiers: 99991248112-DA-N481
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Opiates; Healthy

Keywords

Methamphetamine; Amphetamines; Opiates; Oral Opiates (poppy seeds); Intranasal amphetamines

Outcome Measures

Primary Outcomes (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)

• Heart rates, blood pressure, respiratory rate

  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.

  2 years

Interventions

Vicks VapoInhaler DRUG

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

Poppy seeds OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• 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.

  PMID: 10212860 BACKGROUND

• 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.

  PMID: 18981044 BACKGROUND

• 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.

  PMID: 3979930 BACKGROUND

Study Officials

• Marilyn Huestis, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: July 19, 2012
• Primary Completion: January 31, 2014
• Study Completion: January 31, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-03-19

Locations

US (1)