Status:
WITHDRAWN
Vaping High vs. Low Nicotine E-Liquid
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cardiovascular Risk Factor
Nicotine Dependence
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36...
Detailed Description
This is a within-subjects, crossover design of advanced electronic cigarette users in which we will examine nicotine pharmacokinetics, subjective effects, daily nicotine intake and nicotine titration,...
Eligibility Criteria
Inclusion
- Healthy on the basis of medical history and limited physical examination, as described below:
- Heart rate \< 105 beats per minute (BPM)\*
- Systolic Blood Pressure \< 160 and \> 90\*
- Diastolic Blood Pressure \< 100 and \> 50\*
- \*Considered out of range if both machine and manual readings are above/below these thresholds.
- Age: \>= 21 years
- Age: \<= 70 years
- Current regular user of open tank electronic cigarette (EC) (at least 20 times in the past 30 days) with e-liquid nicotine of 3-6 mg/mL.
- Non-smoker or non-daily cigarette smokers agreeing to abstain from cigarettes for the duration of the study.
- Saliva cotinine \>50 ng/mL and/or NicAlert=6
- Carbon monoxide \>= 5 ppm or per discretion of Principal Investigator
Exclusion
- Medical
- Heart disease
- Seizures
- Cancer
- Thyroid disease (okay if controlled with medication)
- Diabetes
- Hepatitis B or C or Liver disease
- Glaucoma
- Kidney disease or urinary retention
- History of stroke
- An ulcer in the past year
- Active use of an inhaler for Asthma or Chronic obstructive pulmonary disease (COPD)
- Psychiatric conditions
- Current or past schizophrenia, and/or current or past bipolar disorder
- Major depression, current or within the past year
- Major personality disorder
- Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI and considered for inclusion
- History of psychiatric hospitalizations is not exclusionary, but study participation will be determined as per PI's approval
- Drug/Alcohol Dependence
- Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program
- Positive toxicology test for illicit drugs at the screening visit (THC \& prescribed medications okay)
- Opioid replacement therapy (including methadone, buprenorphine, or other)
- Psychiatric medications
- Current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitors (SSRIs) and serotonin-norepinephrine reuptake Inhibitors (SNRIs) and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate.
- Medications
- Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
- Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
- Concurrent use of nicotine-containing medications
- Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment
- Other/Misc. Chronic Health Conditions
- Oral thrush
- Fainting (within the last 30 days)
- Other "life threatening illnesses" as per PI's discretion
- Pregnancy
- Pregnancy (self-reported and urine pregnancy test)
- Breastfeeding (determined by self-report)
- Concurrent participation in another clinical trial
- Inability to read and write in English
- Planning to quit vaping within the next 60 days
- Concurrent regular use of marijuana (occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study)
- Use of other tobacco products, smokeless tobacco, pipes, cigars/cigarillos, blunts/spliffs (no more than 10 times in the past month and must agree to abstain from their use during the period of the study)
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04047836
Start Date
June 1 2023
End Date
December 31 2023
Last Update
August 22 2023
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94110
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110