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New treatment option for Driving Under the Influence
Official title Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes
ClinicalTrials.gov ID: NCT05526196
What this study is testing
What is Cannabis?
Cannabis is an investigational medicine, being studied as a potential treatment for driving under the influence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.