Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

NCT06293040 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00434441R01DA052295
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).

Conditions

Cannabis Intoxication; Alcohol Intoxication

Outcome Measures

Primary Outcomes (13)

• 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).

  Up to 6 hours

• 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). Score ranges from 0-90, with 0 representing no correct trials and 90 representing 100% correct trials.

  Up to 6 hours

• 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). There is no maximum score, with a score of 0 representing either no trials completed or no correct trials. The score reflects the number of correct trials.

  Up to 6 hours

• 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. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.

  Up to 6 hours

• 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.

  Up to 6 hours

• Drug Effect Questionnaire (DEQ) - 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.

  Up to 6 hours

• Drug Effect Questionnaire (DEQ) - 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.

  Up to 6 hours

• Drug Effect Questionnaire (DEQ) - 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.

  Up to 6 hours

• 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).

  Up to 6 hours

• 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).

  Up to 6 hours

• 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)

  Up to 6 hours

• 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.

  Up to 6 hours

• 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. There is no upper or lower limit to possible scores.

  Up to 6 hours

Secondary Outcomes (19)

• Driving performance as assessed by standard deviation of speed (SDSP)

  Up to 6 hours

• Driving performance (mean speed)

  Up to 6 hours

• Driving performance (number of speed exceedances)

  Up to 6 hours

• Driving performance (number of accidents)

  Up to 6 hours

• Driving performance (total rule violations)

  Up to 6 hours

Study Arms (7)

Placebo cannabis + placebo alcohol

PLACEBO COMPARATOR

Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.

Drug: Placebo Cannabis; Drug: Placebo Alcohol

Low dose cannabis with placebo alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.

Drug: Cannabis; Drug: Placebo Alcohol

High dose cannabis with placebo alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.

Drug: Cannabis; Drug: Placebo Alcohol

Low dose cannabis with low dose alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC).

Drug: Cannabis; Drug: Alcohol

High dose cannabis with low dose alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).

Drug: Cannabis; Drug: Alcohol

Placebo cannabis + low dose alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).

Drug: Alcohol; Drug: Placebo Cannabis

Placebo cannabis + high dose alcohol

EXPERIMENTAL

Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).

Drug: Alcohol; Drug: Placebo Cannabis

Interventions

Cannabis DRUG

Cannabis will be vaporized using the Mighty Medic

Also known as: THC

High dose cannabis with low dose alcohol; High dose cannabis with placebo alcohol; Low dose cannabis with low dose alcohol; Low dose cannabis with placebo alcohol

Alcohol DRUG

Alcohol will be orally ingested via a flavored drink

Also known as: Ethanol

High dose cannabis with low dose alcohol; Low dose cannabis with low dose alcohol; Placebo cannabis + high dose alcohol; Placebo cannabis + low dose alcohol

Placebo Cannabis DRUG

Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.

Also known as: Placebo

Placebo cannabis + high dose alcohol; Placebo cannabis + low dose alcohol; Placebo cannabis + placebo alcohol

Placebo Alcohol DRUG

A non-alcoholic, placebo, flavored drink will be orally ingested.

Also known as: Placebo

High dose cannabis with placebo alcohol; Low dose cannabis with placebo alcohol; Placebo cannabis + placebo alcohol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have provided written informed consent
• Be at least 21 years of age
• 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 not donated blood in the prior 30 days
• Report at least 1 day of binge drinking in the past 3 months (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
• Report at least 1 use of cannabis in the past 3 years
• 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 lifetime instance of simultaneous alcohol and cannabis use
• Current concomitant prescription medication use that may interact with the investigational study drug, including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B

You may not qualify if:

• Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
• History of or current evidence of significant medical condition that would put the participant at risk
• Evidence of current psychiatric condition (MINI for DSM-V)
• Meet criteria for severe alcohol use disorder (MINI for DSM-V)
• CIWA-Ar score \> 9
• Use of cannabis, on average, more than 3 days/week over past 3 months
• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

nabiximols; Dronabinol; Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Alcohols

Study Officials

• Tory Spindle, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tory Spindle, PhD

CONTACT

410-550-0529; tspindle@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 5, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)