Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01736332
Eligibility Criteria:
* INCLUSION CRITERIA:
* 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
EXCLUSION CRITERIA:
* 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
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01736332
Study Brief:
Protocol Section:
NCT01736332