Effect of Cannabis on E-Cigarette Use Behavior
- Conditions
- Cannabis UseTobacco UseElectronic Cigarette Use
- Interventions
- Drug: E-Cigarette Full NicotineDrug: E-Cigarette Placebo Nicotine
- Registration Number
- NCT06609109
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.
- Detailed Description
A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of electronic cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on e-cigarette use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Vaporized THC THC 0mg Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Smoked THC THC High Dose Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Smoked THC THC Low Dose Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Smoked THC THC 0mg Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Smoked THC E-Cigarette Full Nicotine Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Smoked THC E-Cigarette Placebo Nicotine Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Vaporized THC THC High Dose Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Vaporized THC THC Low Dose Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Vaporized THC E-Cigarette Full Nicotine Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Vaporized THC E-Cigarette Placebo Nicotine Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine.
- Primary Outcome Measures
Name Time Method Demand Intensity 45 minutes after THC or placebo administration Consumption of e-cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).
Demand Elasticity 45 minutes after THC or placebo administration Changes in e-cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).
- Secondary Outcome Measures
Name Time Method Minnesota Nicotine Withdrawal Scale (MNWS) Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). Primary outcomes will be the peak change from baseline.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1 Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Self report assessment smoking urges. Factor 1 - Intention/Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2 Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Self report assessment smoking urges. Factor 2 - Relief of Negative Affect \& Urgent Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Drug Effect Questionnaire for Like Drug Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. The Drug Effect Questionnaire will be administered using a visual analog scale. Participants place a mark on a 100mm line with the left endpoint labeled Not at All and the right endpoint labeled Extremely. Primary outcomes will be the peak change from baseline.
Heart Rate Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Heart rate will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Diastolic Blood Pressure Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Diastolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Systolic Blood Pressure Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Systolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Divided Attention Task (DAT) Performance Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration. Participants will complete a Divided Attention Task (DAT) in which the participants must simultaneously track a stimulus moving horizontally on a computer screen and respond to visual stimuli presented. The primary dependent measure is the average distance maintained from the target stimulus. Primary outcomes will be the peak change from baseline.
Trial Locations
- Locations (1)
Johns Hopkins University Behavioral Pharmacology Research Unit
🇺🇸Baltimore, Maryland, United States