Back to resultsThe Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
Primary Purpose
Cannabis Intoxication, Alcohol Intoxication
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Alcohol
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis Intoxication
Eligibility Criteria
Inclusion Criteria:
- Have provided written informed consent
- Be between the ages of 21 and 50
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- Have not donated blood in the prior 30 days.
- Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
- Report ≥ 5 uses of cannabis in the past year
- Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
- Report at least 1 instance of simultaneous alcohol and use in the past year.
Exclusion Criteria:
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
- History of or current evidence of significant medical condition
- Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score > 9
- Been in treatment previously for alcohol or cannabis use disorder
- Use of cannabis, on average, more than 2 times/week over past 3 months
- Liver function tests more than 2x normal range
- Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
- Shipley vocabulary score <18 (corresponds to 5th grade reading level).
Sites / Locations
- Johns Hopkins Behavioral Pharmacology Research UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo cannabis + placebo alcohol
low dose cannabis with placebo alcohol
high dose cannabis with placebo alcohol
low dose cannabis with low dose alcohol
high dose cannabis with low dose alcohol
Placebo cannabis + low dose alcohol
Placebo cannabis + high dose alcohol
Arm Description
Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Outcomes
Primary Outcome Measures
DRUID application global impairment score
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Correct Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Cumulative score on Field Sobriety Tests
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance. We will report the cumulative amount of clues observed across these tasks (out of a possible 22 clues).
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Feel High
The DEQ will be used to obtain subjective ratings of "feel high". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Confidence to Drive
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Willingness to Drive
The DEQ will be used to obtain subjective ratings of "willingness to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Biphasic alcohol effects scale (BAES) - Sedative Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70).
Biphasic alcohol effects scale (BAES) - Stimulant Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70).
Subjective high assessment scale (SHAS)
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol. These items are integrated to produce an overall SHAS score (0-130)
Driving performance as assessed by standard deviation of lateral position (SDLP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Driving performance as assessed by composite drive score
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores
Secondary Outcome Measures
Driving performance as assessed by standard deviation of speed (SDSP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDSP will be determined during each drive; this measure quantifies the variability in speed (in MPH) observed.
Driving performance (mean speed)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Mean speed (in MPH) over the course of each drive will be determined.
Driving performance (number of speed exceedances)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of times participants exceed the allowable speed limit during each drive.
Driving performance (number of accidents)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of accidents (including car collisions, pedestrians hit, etc.) during each drive.
Driving performance (total rule violations)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) during each drive.
Driving performance (distance to lead vehicles)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The mean distance (in meters) maintained to lead vehicles during car-following segments of each drive.
Attempted Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. The number of attempted trials will be recorded
Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Percentage of correct trials out of those attempted will be recorded
Reaction time on Paced Auditory Serial Addition Task
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The mean reaction time (in milliseconds) to select correct responses will be recorded.
Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Impairment will be assessed using performance on the Horizontal Gaze Nystagmus Test (HGN). Total score will be recorded (out of possible 6 clues) with higher scores indicating higher impairment.
Field Sobriety Test - Score on Walk and Turn test
Impairment will be assessed using performance on the the Walk and Turn. Total score will be recorded (out of a possible 8 clues) with higher scores indicating higher impairment.
Field Sobriety Test - Score on One Leg Stand
Impairment will be assessed using performance on the One Leg Stand test. Total score will be recorded (out of a possible 4 clues) with higher scores indicating higher impairment.
Field Sobriety Test - Score on Modified Romberg Balance
Impairment will be assessed using performance on the Modified Romberg Balance test. Total score will be recorded (out of a possible 4 clues) with higher scores indicating higher impairment.
Drug Effect Questionnaire - Like Drug Effect
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Want more
The DEQ will be used to obtain subjective ratings of "want more". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Dislike Drug Effect
The DEQ will be used to obtain subjective ratings of "dislike drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Pharmacokinetics - CMax for THC and THC metabolites
Whole blood concentrations of THC, 11-OH- THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration reached for each individual. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Pharmacokinetics - AUC for THC and THC metabolites
Whole blood concentrations of THC, 11-OH- THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Pharmacokinetics - Breath Alcohol Concentration (BAC)
BAC will be measured using the Alco-Sensor IV. Measuring BAC is needed to confirm that participants reached the targeted BAC for a given session and to confirm adherence to pre-session alcohol abstinence requirements.
Full Information
NCT ID
NCT04931095
First Posted
June 11, 2021
Last Updated
March 29, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04931095
Brief Title
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
Official Title
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
Detailed Description
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Intoxication, Alcohol Intoxication
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
All participants will complete all dose conditions (study arms) in a randomized order
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo cannabis + placebo alcohol
Arm Type
Placebo Comparator
Arm Description
Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
Arm Title
low dose cannabis with placebo alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
Arm Title
high dose cannabis with placebo alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
Arm Title
low dose cannabis with low dose alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
Arm Title
high dose cannabis with low dose alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Arm Title
Placebo cannabis + low dose alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Arm Title
Placebo cannabis + high dose alcohol
Arm Type
Experimental
Arm Description
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Cannabis will be orally ingested via a brownie
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Alcohol will be orally ingested via a flavored drink
Primary Outcome Measure Information:
Title
DRUID application global impairment score
Description
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Time Frame
7.5 hours
Title
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Description
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Time Frame
7.5 hours
Title
Correct Trials on the Digit Symbol Substitution Task (DSST)
Description
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Time Frame
7.5 hours
Title
Cumulative score on Field Sobriety Tests
Description
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance. We will report the cumulative amount of clues observed across these tasks (out of a possible 22 clues).
Time Frame
7.5 hours
Title
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Description
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Drug Effect Questionnaire - Feel High
Description
The DEQ will be used to obtain subjective ratings of "feel high". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Drug Effect Questionnaire - Confidence to Drive
Description
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Drug Effect Questionnaire - Willingness to Drive
Description
The DEQ will be used to obtain subjective ratings of "willingness to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Biphasic alcohol effects scale (BAES) - Sedative Score
Description
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70).
Time Frame
7.5 hours
Title
Biphasic alcohol effects scale (BAES) - Stimulant Score
Description
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70).
Time Frame
7.5 hours
Title
Subjective high assessment scale (SHAS)
Description
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol. These items are integrated to produce an overall SHAS score (0-130)
Time Frame
7.5 hours
Title
Driving performance as assessed by standard deviation of lateral position (SDLP)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Time Frame
7.5 hours
Title
Driving performance as assessed by composite drive score
Description
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores
Time Frame
7.5 hours
Secondary Outcome Measure Information:
Title
Driving performance as assessed by standard deviation of speed (SDSP)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDSP will be determined during each drive; this measure quantifies the variability in speed (in MPH) observed.
Time Frame
7.5 hours
Title
Driving performance (mean speed)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Mean speed (in MPH) over the course of each drive will be determined.
Time Frame
7.5 hours
Title
Driving performance (number of speed exceedances)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of times participants exceed the allowable speed limit during each drive.
Time Frame
7.5 hours
Title
Driving performance (number of accidents)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of accidents (including car collisions, pedestrians hit, etc.) during each drive.
Time Frame
7.5 hours
Title
Driving performance (total rule violations)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The cumulative number of rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) during each drive.
Time Frame
7.5 hours
Title
Driving performance (distance to lead vehicles)
Description
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. The mean distance (in meters) maintained to lead vehicles during car-following segments of each drive.
Time Frame
7.5 hours
Title
Attempted Trials on the Digit Symbol Substitution Task (DSST)
Description
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. The number of attempted trials will be recorded
Time Frame
7.5 hours
Title
Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
Description
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Percentage of correct trials out of those attempted will be recorded
Time Frame
7.5 hours
Title
Reaction time on Paced Auditory Serial Addition Task
Description
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The mean reaction time (in milliseconds) to select correct responses will be recorded.
Time Frame
7.5 hours
Title
Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Description
Impairment will be assessed using performance on the Horizontal Gaze Nystagmus Test (HGN). Total score will be recorded (out of possible 6 clues) with higher scores indicating higher impairment.
Time Frame
Up to 7.5 hours
Title
Field Sobriety Test - Score on Walk and Turn test
Description
Impairment will be assessed using performance on the the Walk and Turn. Total score will be recorded (out of a possible 8 clues) with higher scores indicating higher impairment.
Time Frame
Up to 7.5 hours
Title
Field Sobriety Test - Score on One Leg Stand
Description
Impairment will be assessed using performance on the One Leg Stand test. Total score will be recorded (out of a possible 4 clues) with higher scores indicating higher impairment.
Time Frame
Up to 7.5 hours
Title
Field Sobriety Test - Score on Modified Romberg Balance
Description
Impairment will be assessed using performance on the Modified Romberg Balance test. Total score will be recorded (out of a possible 4 clues) with higher scores indicating higher impairment.
Time Frame
Up to 7.5 hours
Title
Drug Effect Questionnaire - Like Drug Effect
Description
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Drug Effect Questionnaire - Want more
Description
The DEQ will be used to obtain subjective ratings of "want more". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Drug Effect Questionnaire - Dislike Drug Effect
Description
The DEQ will be used to obtain subjective ratings of "dislike drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
7.5 hours
Title
Pharmacokinetics - CMax for THC and THC metabolites
Description
Whole blood concentrations of THC, 11-OH- THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration reached for each individual. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Time Frame
7.5 hours
Title
Pharmacokinetics - AUC for THC and THC metabolites
Description
Whole blood concentrations of THC, 11-OH- THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Time Frame
Up to 7.5 hours
Title
Pharmacokinetics - Breath Alcohol Concentration (BAC)
Description
BAC will be measured using the Alco-Sensor IV. Measuring BAC is needed to confirm that participants reached the targeted BAC for a given session and to confirm adherence to pre-session alcohol abstinence requirements.
Time Frame
Up to 7.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have provided written informed consent
Be between the ages of 21 and 55
Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have not donated blood in the prior 30 days.
Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
Report ≥ 1 use of cannabis in the past year
Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
Report at least 1 instance of simultaneous alcohol and use in the past year.
Exclusion Criteria:
Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
History of or current evidence of significant medical condition
Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
Meet criteria for severe alcohol use disorder (MINI for DSM-V)
Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score > 9
Been in treatment previously for alcohol or cannabis use disorder
Use of cannabis, on average, more than 2 times/week over past 3 months
Liver function tests more than 2x normal range
Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
Shipley vocabulary score <18 (corresponds to 5th grade reading level).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tory Spindle, PhD
Phone
410-550-0529
Email
tspindle@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tory Spindle, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spencer Lin
Email
slin96@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
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