Vaping THC From Electronic Cigarettes
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Nicotine; Cannabis; PAX Loose Leaf Vaporizer
Intervention description: Participants will vape tobacco leaves with nicotine out of the PAX device.; Participants will vape marijuana leaves with nicotine out of the PAX device.; In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: THC; Tobacco; Vaping

Summary:

      This study aims to understand THC pharmacology and the safety of cannabis vaping, including
      the pharmacology and safety of co-administration of nicotine and THC. The study is designed
      as a within-subjects single-blinded crossover study. Fourteen smokers of tobacco cigarettes
      and cannabis will switch between three conditions, namely: (a) vaping cannabis leaf, (b)
      vaping tobacco containing nicotine and (c) vaping a combination of cannabis leaf and tobacco
      containing nicotine. All participants will vape each product with the PAX loose-leaf
      vaporizer. The study will be conducted during three outpatient visits separated by at least
      48 hours. The order of treatment (cannabis leaf, tobacco with nicotine, cannabis leaf &
      tobacco with nicotine) will be counterbalanced between subjects. Subjects will be blinded to
      the content of the vaporizer on the study day but will be told during screening that they
      will vape cannabis alone, tobacco alone, and cannabis plus tobacco with nicotine.
    

Eligibility criteria:

        Inclusion

          -  Age >=21 years <=70 years

          -  Regular user of tobacco cigarettes (daily or most days)

          -  Regular user of cannabis in any form (combusted or ingested) at least 5 days out of
             the month.

          -  Positive for Tetrahydrocannabinol (THC) on screening toxicology test

          -  Willing to abstain from tobacco smoking and all other combustible products (ex:
             cigars) for 12 hours prior to each outpatient hospital admission.

          -  Willing to abstain from smoking/ingesting cannabis for 12 hours prior to each
             outpatient hospital admission.

          -  Willing to abstain from using any kind of nicotine products for 12 hours prior to each
             outpatient hospital admission (ex: electronic cigarettes, nicotine replacement
             therapy).

          -  Saliva cotinine ≥ 30 ng/mL and/or NicAlert of 6

          -  Healthy (based on limited physical examination and medical history collected during
             screening)

          -  Heart rate < 105 beats per minute (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

        Exclusion

          -  Medical (The following unstable medical conditions):

          -  Heart disease

          -  Uncontrolled hypertension

          -  Thyroid disease (okay if controlled with medication)

          -  Diabetes

          -  Hepatitis B or C or Liver disease

          -  Glaucoma

          -  Prostatic hypertrophy

          -  History of paranoia after marijuana use

          -  Psychiatric conditions

          -  Current or past schizophrenia, and/or current or past bipolar disorder

          -  Adult onset Attention-deficit/hyperactivity disorder (ADHD) (if being treated)

          -  Participants with current or past depression and/or anxiety disorders will be reviewed
             by the study physician and considered for inclusion

          -  History of psychiatric hospitalizations are not exclusionary, but study participation
             will be determined as per study physician'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 and are currently
             abstaining from drug and alcohol

          -  Positive toxicology test at the screening visit (THC & prescribed medications okay)

          -  Methadone replacement therapy

          -  Scoring a 2 or higher on the Severity of Dependence Scale for cannabis use.

          -  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 study physician that the participant is
             otherwise healthy, stable, and able to participate.

          -  Other Medications

          -  Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example:
             rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs).

          -  Concurrent use of nicotine-containing medications

          -  Other/Misc. Chronic Health Conditions

          -  Oral thrush

          -  Fainting

          -  Untreated thyroid disease

          -  Other "life threatening illnesses" as per study physician's discretion

          -  Use of Other Tobacco Products (OTP); any of the following products in combination more
             than 15 times in the past month

          -  smokeless tobacco

          -  pipes

          -  cigars, cigarillos

          -  blunts, spliffs

          -  Pregnancy

          -  Pregnancy (self-reported and urine pregnancy test)

          -  Breastfeeding (determined by self-report)

          -  Concurrent participation in another clinical trial

          -  Inability to communicate in English

          -  Planning to quit smoking or cannabis use within the next 60 days