Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Johns Hopkins University

Status and phase: Enrolling; Phase 1

Conditions: Cannabis Intoxication; Alcohol Intoxication

Treatments: Drug: Placebo Alcohol; Drug: Cannabis; Drug: Placebo Cannabis; Drug: Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06293040

R01DA052295 (U.S. NIH Grant/Contract)

IRB00434441

Details and patient eligibility

About

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).

Full description

This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 7 experimental drug administration sessions in randomized order where the participant will vaporize cannabis-containing capsules (or "pods") (containing 0, 5, or 25mg THC) with a drink that contains no alcohol or alcohol (alcohol-containing drinks will be calculated to produce a breath alcohol concentration, BAC, of 0.05%). There is also a positive control session where participants will vaporize placebo cannabis with an alcohol drink calculated to produce a BAC of 0.08%. Each session will last approximately 8 hours and will be separated by at least 48 hours to allow for sufficient drug washout. Participants may complete up to 2 sessions per week. Drugs will be administered in a double-blind and double-dummy fashion (i.e., participants will always receive both active or placebo cannabis and active or placebo alcohol). During each session, a battery of assessments including blood collection, subjective questionnaire administration, cognitive performance testing, and simulated driving will be conducted.

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have provided written informed consent
2. Be at least 21 years of age
3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
4. 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
5. Have not donated blood in the prior 30 days
6. 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)
7. Report at least 1 use of cannabis in the past 3 years
8. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
9. Report at least 1 lifetime instance of simultaneous alcohol and cannabis use
10. 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

Exclusion criteria

1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
2. History of or current evidence of significant medical condition that would put the participant at risk
3. Evidence of current psychiatric condition (MINI for DSM-V)
4. Meet criteria for severe alcohol use disorder (MINI for DSM-V)
5. CIWA-Ar score > 9
6. Use of cannabis, on average, more than 3 days/week over past 3 months
7. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
8. Shipley vocabulary score <18 (corresponds to 5th grade reading level)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 7 patient groups, including a placebo group

Placebo cannabis + placebo alcohol

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Cannabis

Drug: Placebo Alcohol

Low dose cannabis with placebo alcohol

Experimental group

Description:

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

Treatment:

Drug: Cannabis

Drug: Placebo Alcohol

High dose cannabis with placebo alcohol

Experimental group

Description:

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

Treatment:

Drug: Cannabis

Drug: Placebo Alcohol

Low dose cannabis with low dose alcohol

Experimental group

Description:

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

Treatment:

Drug: Alcohol

Drug: Cannabis

High dose cannabis with low dose alcohol

Experimental group

Description:

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

Treatment:

Drug: Alcohol

Drug: Cannabis

Placebo cannabis + low dose alcohol

Experimental group

Description:

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

Treatment:

Drug: Placebo Cannabis

Drug: Alcohol

Placebo cannabis + high dose alcohol

Experimental group

Description:

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

Treatment:

Drug: Placebo Cannabis

Drug: Alcohol