Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Co-administration of cannabis and tobacco is a common practice, but there is little experimental evidence aimed at understanding the reasons for this prevalence. Some preliminary evidence suggests that tobacco may actually counteract the cognitive-impairing effects of cannabis, and may also increase the subjective ('liking') effects of cannabis, but results are inconclusive. Further, there are no studies into the effects of tobacco on other cannabis-related harms such as driving, or on the ability of tobacco to alter the blood levels of THC, the chemical responsible for the psychoactive properties of cannabis. The purpose of the present study will be to evaluate the effects of tobacco, cannabis or combinations of tobacco and cannabis on driving, cognition, subjective effects and blood THC. Driving will be assessed using a state-of-the-art driving simulator that allows for the safe and objective measurement of the effects of intoxicating substances on driving. Participants will be regular users of cannabis and will be invited to the lab for four counterbalanced test sessions. In these test sessions they will drive the simulator and undergo cognitive tests before and after smoking: 1) cannabis; 2) tobacco; 3) cannabis + tobacco; or 4) placebo. Outcomes will be measured at several time points after smoking the product. Participants will also give blood for determination of levels of THC, and will complete subjective effects questionnaires both before and after smoking the cigarette. This study will be one of the first experimental laboratory studies of the reasons behind co-administration of tobacco and cannabis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of THC and Alcohol on Driving Performance

NCT03555968

Cannabis Alcohol Drinking Accident, Traffic

WITHDRAWN PHASE4

Alcohol Effects on Driving-related Skills of Young Drivers

NCT02710578

Psychomotor Impairment

COMPLETED NA

Age Differences in the Effects of Cannabis on Simulated Driving

NCT04325958

Cannabis

RECRUITING NA

Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression

NCT04935619

Cannabis Use Major Depressive Disorder Cognitive Impairment

RECRUITING NA

Combined Alcohol and Cannabis Effects on Skills of Young Drivers

NCT03106363

Psychomotor Impairment

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Driving Under the Influence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

A cigarette containing placebo cannabis and placebo tobacco

Group Type OTHER

Placebo

Intervention Type DRUG

Dried flower cigarette with both placebo tobacco and cannabis

Tobacco

A cigarette with placebo cannabis and active tobacco

Group Type OTHER

Tobacco

Intervention Type DRUG

Dried flower cigarette with active nicotine

Cannabis

A cigarette with active cannabis and placebo tobacco

Group Type OTHER

Cannabis

Intervention Type DRUG

Dried flower cannabis cigarette with 22% THC

Tobacco and cannabis

A cigarette with active cannabis and active tobacco

Group Type OTHER

Cannabis tobacco

Intervention Type DRUG

Dried flower cigarette with active nicotine and cannabis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabis

Dried flower cannabis cigarette with 22% THC

Intervention Type DRUG

Tobacco

Dried flower cigarette with active nicotine

Intervention Type DRUG

Cannabis tobacco

Dried flower cigarette with active nicotine and cannabis

Intervention Type DRUG

Placebo

Dried flower cigarette with both placebo tobacco and cannabis

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Adults aged 19 years to 45 years (to control for the effects of age on cognition)

* Smoke or vape cannabis at least once a month but no more than 4 times a week (to avoid enrolling people with cannabis use disorder who may experience withdrawal when asked to abstain from cannabis)
* Experience with smoked cannabis in the past year
* Report use of at least 100 cigarettes in their lifetime to ensure familiarity with the tobacco used in the present study
* Use of any nicotine (smoked, vaped, etc) in the past year
* G2 or full G driver's licence for at least a year
* Willing to abstain from alcohol and other drugs (other than drugs required for treatment of a medical condition) for 48 hours prior to study session
* Normal heart rate and blood pressure as determined by the QI (because cannabis and tobacco increase heart rate)
* Normal ECG (because cannabis and tobacco increase heart rate)
* Willing to abstain from cannabis for 72 hours prior to the test session and from smoking tobacco for 12 hours
* Willing to use an accepted form of contraception during the study (both males and females)
* Past lifetime experience with co-use of cannabis or tobacco (either simultaneous or concurrent)
* Provides written and informed consent

Exclusion Criteria

* • Use of psychoactive medications or drugs

* Current alcohol or other substance use disorder, including cannabis (as assessed with the SCID)
* Current or past nicotine dependence (to avoid precipitating a relapse)
* Withdrawal symptoms as assessed with the Marijuana Withdrawal Checklist \[57, 58\]
* A score of less than 10 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) \[59\]
* Family history of schizophrenia or psychosis (to avoid giving cannabis to anyone with a predisposition to psychosis)
* Respiratory illnesses (due to the smoked route of administration in this study)
* Any serious medical condition precluding participation as judged by the responsible study physician
* Pregnancy or breastfeeding
* Negative urine screen for cannabis at eligibility assessment (to ensure experience with cannabis)
* Neurological disorders that may affect cognitive function
* Treatment-seeking for tobacco or cannabis use
* Use of more than 5 cigarettes a day (to avoid confound of the effects of chronic smoking on measures)
* Concomitant therapy with sedative-hypnotics or other psychoactive drugs (counter-indicated with cannabis)

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes