Study Summary
This trial will study how cannabis and nicotine affect each other when used together.
Eligible Conditions
- Cannabis
- Nicotine
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 5 hours
5 hours
Amount of nicotine (mL of smoke/vapor) inhaled
Behavioral task performance as assessed by the DRUID app
Cannabis Craving as assessed by the Cannabis Craving Questionnaire
Trigger Finger Disorder
Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
Tobacco Craving as assessed by the Tobacco Craving Questionnaire
Memory
Trial Safety
Safety Progress
Trial Design
7 Treatment Groups
Active cannabis with high nicotine e-cigarette
1 of 7
Active cannabis without nicotine
1 of 7
Placebo cannabis with high nicotine e-cigarette
1 of 7
Active cannabis with own brand cigarettes
1 of 7
Placebo cannabis with low nicotine e-cigarette
1 of 7
Active cannabis with low nicotine e-cigarette
1 of 7
placebo cannabis with own brand cigarettes
1 of 7
Experimental Treatment
60 Total Participants · 7 Treatment Groups
Primary Treatment: Cannabis · No Placebo Group · Phase 1
Active cannabis with high nicotine e-cigaretteExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
Active cannabis without nicotine
Drug
Experimental Group · 1 Intervention: Cannabis · Intervention Types: DrugPlacebo cannabis with high nicotine e-cigaretteExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
Active cannabis with own brand cigarettesExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
Placebo cannabis with low nicotine e-cigaretteExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
Active cannabis with low nicotine e-cigaretteExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
placebo cannabis with own brand cigarettesExperimental Group · 2 Interventions: Nicotine, Cannabis · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Medical Cannabis
Not yet FDA approved
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 hours
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,245 Previous Clinical Trials
5,619,340 Total Patients Enrolled
3 Trials studying Nicotine
111 Patients Enrolled for Nicotine
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,165 Total Patients Enrolled
Ryan VandreyPrincipal InvestigatorJohns Hopkins University
Eligibility Criteria
Age 18 - 55 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:We have agreed to provide written consent.
You must be between the ages of 18 and 55.
Based on a physical examination, a medical history, vital signs, and screening urine and blood tests, be in good general health.
The person tested negative for drugs of abuse, except cannabis, via urine sample, and alcohol via breath sample, at the screening visit and upon arrival for each experimental session.
Women who are not pregnant or nursing, and who have negative serum and urine pregnancy tests at the screening visit, will be allowed to participate in the study.
The article states that the person's blood pressure at the screening visit must be below 150 mmHg for systolic blood pressure and below 90 mmHg for diastolic blood pressure.
Not donated blood in the past 30 days.
Report any experience you have had of inhaling cannabis.
The survey found that people who use cannabis at least 5 times in the past year are more likely to experience psychotic-like symptoms.
Who else is applying?
What state do they live in?
| District of Columbia | 33.3% |
| Ohio | 16.7% |
| Virginia | 16.7% |
| Other | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Johns Hopkins University | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 60.0% |
| Met criteria | 40.0% |
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Johns Hopkins University: < 24 hours
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Conditions
Cancer Related
Treatments