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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA057228 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety
PRIMARY OBJECTIVE:
I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.
SECONDARY OBJECTIVES:
I. Safety
PRIMARY OBJECTIVE:
I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.
SECONDARY OBJECTIVES:
I. Safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Vape followed by Joint) | Experimental | Patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. 7 to 14 days later patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. Patients also undergo blood sample collection throughout the study. |
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| Arm II (Joint followed by Vape) | Experimental | Patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. 7 to 14 days later patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. Patients also undergo blood sample collection throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vape device | Behavioral | Consume THC via vape defice |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex | From baseline to 360 minutes after consuming product |
| Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360) | Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex. | From baseline to 360 minutes after consuming product |
| Time to maximum concentration of THC in plasma (Tmax) | Blood samples will be collected for plasma levels of THC.All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex. | From baseline to 360 minutes after consuming product |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Number of subjects who experienced an adverse event during the study . | Up to 360 minutes after consuming product |
| Puffing behaviors | Measure changes in subject puffing behavior by mean number of puffs and duration |
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Inclusion Criteria:
Exclusion Criteria:
• Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Smith | Contact | 8772757724 | askroswell@roswellpark.org |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Smith | Roswell Park Comprehensive Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Joint | Behavioral | Consume THC via joint |
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| Marijuana via vape device | Drug | Given via vape device |
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| Marijuana via joint | Drug | Given via joint |
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| Through study completion, an average of 14 days |
| Short term effects of THC | The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use. | Through Study completion, an average of 14 days |
| Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST) | computerized sensitive and valid assessment of cognitive dysfunction that correlates with real-world functional ability to complete daily tasks. The outcome is the total number of correct responses. | Through study completion, an average of 14 days |
| Paced Auditory Serial Addition Task (PASET) | a validated measure used to assess attention, concentration, working memory, and information processing. | Through study completion , an average of 14 days |