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Eligibility
for people ages 21 years to 70 years
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Neal L Benowitz

Description

Summary

This study will investigate the delivery, systemic exposure, subjective and physiologic effects of THC vaped from e-cigarettes.

Official Title

Intake and Pharmacokinetics of THC Vaped From Electronic Cigarettes

Details

Electronic cigarettes (e-cigarettes) have proliferated at a rapid rate since their introduction into the US market in 2007 and their use as a form of nicotine delivery far outpaced the science base. Important questions revolved around their abuse liability and safety. Although the design of these devices continues to evolve, the investigators have previously described nicotine intake, systemic retention, pharmacokinetics, and effects, as well as vaping behavior and self-administration of e-cigarettes. The investigators showed that e-cigarettes deliver as much nicotine from 15 puffs as a typical tobacco cigarette (~1 mg), most of which is systemically retained, and the shape of the plasma nicotine concentration-time curve is also similar to tobacco cigarettes, except that the maximum plasma nicotine concentration is, on average, lower for e-cigarettes. During ad libitum access, e-cigarettes were vaped intermittently in groups of 2-5 puffs or single puffs such that plasma nicotine levels rose gradually and peaked at the end of the 90-minute session. This differs from the rapid increase in plasma nicotine observed during controlled use of e-cigarettes or during tobacco cigarette smoking. Taken together, these results indicate that e-cigarettes have the potential to produce and sustain nicotine addiction but their use and abuse liability may differ from tobacco cigarette.

Marijuana is the most widely used illicit drug. While marijuana has traditionally been combusted, vaping of either loose leaf marijuana or other forms of tetrahydrocannabinol (THC) extracts has been increasing. The latest national data show that 7.6% of current marijuana users (past 30 days) and 9.9% of ever marijuana users (lifetime) administered THC through a vaporizer or electronic device (the study did not differentiate between vaporizers and electronic devices like e-cigarettes). The prevalence of vaped marijuana or THC is higher among younger adults. Prevalence of vaped marijuana/THC among 18-24 and 25-34 year-old ever marijuana users was 19.3% and 16.3%, respectively, compared to 8.8% for 35-49 year-olds and 5.7% for those 50 years and over (6). A recent study also showed high rates of cannabis vaping using e-cigarettes among high school students (18.0% among ever e-cigarette users).

Although e-cigarettes were not designed for use with THC extracts, which are more viscous than nicotine e-liquids, there is an abundance of YouTube videos demonstrating how to modify nicotine e-cigarettes for use with THC extracts as well as how to prepare THC e-liquids. There are also prepackaged cartridges with THC extracts that are compatible with e-cigarette batteries. Yet again, the science base has not kept up with the growing use of these products. The investigators currently have no data on THC delivery, pharmacokinetics, and effects of THC vaping with currently marketed e-cigarettes. Further, just as tobacco is mixed with marijuana for nicotinic reinforcement of THC in products such as blunts, it is not inconceivable that THC may also be mixed with nicotine e-liquids when diluting THC extracts. Therefore, it is important to understand the pharmacology and safety of simultaneous intake of nicotine and THC from vaping.

The study is designed as a within-subjects pharmacokinetic comparison. Fourteen (14) e-cigarette users who are also current marijuana/THC users will switch between two THC e-liquid conditions, namely, (a) e-liquid solution containing 40% THC and no nicotine, and (b) e-liquid solution containing 40% THC and 0.6% (6 mg/mL) nicotine, during 2 outpatient visits. The outpatient days will comprise of a fixed-puffing regimen. Study days will be separated by at least 48 hours. The order of treatment (THC only and THC with nicotine) will be counterbalanced between subjects. Subjects will be blinded to the content of the e-cigarette (i.e. THC only vs THC + nicotine).

Keywords

Marijuana Dependence Nicotine Dronabinol

Eligibility

You can join if…

Open to people ages 21 years to 70 years

  • Users of advanced-design nicotine e-cigarettes, including all devices with tanks.Certain rebuildable atomizers (RBAs) will be allowed as long they contain a for the THC oil/e-liquid.
  • Participants must use e-cigarettes at least 25 days per month for past 3 months or longer
  • Saliva cotinine ≥ 30 ng/mL
  • Expired carbon monoxide (CO) less than 5 ppm
  • Preferably non-cigarette smoker and if tobacco cigarette smoker also, must be smoking less than 5 cigarettes per day (CPD)
  • All subjects must be current marijuana users, who have smoked or vaped marijuana or THC extracts at least once a month in past 3 months, contingent on positive THC screening and/or self-reported history of marijuana use.
  • Heart rate < 105 BPM
  • Systolic Blood Pressure < 160 and> 90 [considered out of range if both machine and manual readings are above/below these thresholds]
  • Diastolic Blood Pressure < 100 and> 50 [considered out of range if both machine and manual readings are above/below these thresholds]
  • Body Mass Index ≤ 38.0

You CAN'T join if...

  • The following unstable medical conditions: (Heart disease, Uncontrolled hypertension,Thyroid disease, Hepatitis B or C or Liver disease, Glaucoma, Prostatic hypertrophy)
  • Current or past schizophrenia, current or past adult ADHD, or current or past bipolar disorder
  • Participants with current or past depression and/or anxiety disorders will be reviewed by the study doctor and considered for inclusion
  • Psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study doctor's approval
  • Alcohol or illicit drug dependence within the past 12 months with the exception of those currently in or who have recently completed an alcohol/drug treatment program.
  • Methadone replacement therapy
  • Current regular use of the following psychiatric medications: (Major tranquilizers,Antipsychotics, Antidepressants (with the exception of SSRIs and SNRIs and current evaluation by the study doctor that the participant is otherwise healthy, stable, and able to participate))
  • Use of medications that are inducers of CYP2A6 (a nicotine metabolizing enzyme) such as rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs
  • Other/Misc Health Conditions (Oral thrush, Fainting, Untreated thyroid disease,Urinary retention, Other "life threatening illnesses" as per study doctor's discretion, History of paranoia after marijuana use)
  • Exclusively cartridge or cig-a-like e-cigarette users
  • 0 mg nicotine e-cigarette liquids
  • Pregnancy (self-reported and urine pregnancy test)
  • Breastfeeding (determined by self-report)

Location

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02955329
Lead Scientist
Neal L Benowitz
Study Type
Interventional
Last Updated
November 2016
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