Behavioral Pharmacology of Cannabis and Nicotine

NCT04124432 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB00220975R21DA044377
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.

Conditions

Cannabis; Nicotine

Outcome Measures

Primary Outcomes (1)

• Amount of Nicotine (mL of Smoke/Vapor) Inhaled

  Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.

  0-5 hours

Secondary Outcomes (6)

• Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)

  0-5 hours

• Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)

  0-5 hours

• Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)

  0-5 hours

• Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App

  0-5 hours

• Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire

  0-5 hours

Study Arms (7)

Active cannabis without nicotine

EXPERIMENTAL

Smoked cannabis containing 10mg THC + No nicotine/tobacco

Drug: Cannabis

Active cannabis with own brand cigarettes

EXPERIMENTAL

Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes

Drug: Cannabis; Drug: Nicotine

Active cannabis with low nicotine e-cigarette

EXPERIMENTAL

Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)

Drug: Cannabis; Drug: Nicotine

Active cannabis with high nicotine e-cigarette

EXPERIMENTAL

Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)

Drug: Cannabis; Drug: Nicotine

placebo cannabis with own brand cigarettes

EXPERIMENTAL

Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes

Drug: Cannabis; Drug: Nicotine

Placebo cannabis with low nicotine e-cigarette

EXPERIMENTAL

Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)

Drug: Cannabis; Drug: Nicotine

Placebo cannabis with high nicotine e-cigarette

EXPERIMENTAL

Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)

Drug: Cannabis; Drug: Nicotine

Interventions

Cannabis DRUG

Cannabis will be smoked

Active cannabis with high nicotine e-cigarette; Active cannabis with low nicotine e-cigarette; Active cannabis with own brand cigarettes; Active cannabis without nicotine; Placebo cannabis with high nicotine e-cigarette; Placebo cannabis with low nicotine e-cigarette; placebo cannabis with own brand cigarettes

Nicotine DRUG

Nicotine will be smoked or vaporized

Active cannabis with high nicotine e-cigarette; Active cannabis with low nicotine e-cigarette; Active cannabis with own brand cigarettes; Placebo cannabis with high nicotine e-cigarette; Placebo cannabis with low nicotine e-cigarette; placebo cannabis with own brand cigarettes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 55
• Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
• Test negative for drugs of abuse aside from cannabis (via urine sample) and alcohol (via breath sample) at the screening visit and upon arrival for each experimental session.
• Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
• Have a body mass index (BMI) in the range of 18 to 36 kg/m2
• Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
• Have not donated blood in the prior 30 days.
• Report prior experience inhaling cannabis.
• Report using cannabis at least 5 times in the past year.
• Smoke ≥5 tobacco cigarettes per day on average in the past month.
• Use an e-cigarette at least 15 of the past 30 days.
• Have a breath carbon monoxide (CO) of \>8ppm or urine cotinine \>200ng/mL to confirm current nicotine use status.

You may not qualify if:

• Non-medical use of psychoactive drugs (aside from cannabis) other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
• History of or current evidence of significant medical or psychiatric illness which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
• Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
• Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
• History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
• Epilepsy or a history of seizures.
• Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician
• Individuals with anemia.
• Prior history of allergic or serious adverse reaction to either cannabis or tobacco/nicotine.
• Average use of cannabis more than 2 times per week in the prior 3 months.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Ryan Vandrey
• Organization: Johns Hopkins School of Medicine

rvandrey@jhmi.edu

410-550-4036

Study Officials

• Ryan Vandrey

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo controlled, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: September 15, 2020
• Primary Completion: July 24, 2023
• Study Completion: August 31, 2023
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)