The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment

Johns Hopkins University

Status and phase: Completed; Phase 1

Conditions: Cannabis Intoxication; Alcohol Intoxication

Treatments: Drug: Cannabis; Drug: Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04931095

IRB00290015

1R01DA052295-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have provided written informed consent
2. Be between the ages of 21 and 55
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 a body mass index (BMI) in the range of 19 to 36 kg/m2
6. 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
7. Have not donated blood in the prior 30 days.
8. 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)
9. Report ≥ 1 use of cannabis in the past year
10. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
11. Report at least 1 instance of simultaneous alcohol and use in the past year.

Exclusion criteria

1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
2. 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
3. History of or current evidence of significant medical condition
4. Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
5. Meet criteria for severe alcohol use disorder (MINI for DSM-V)
6. Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score > 9
7. Been in treatment previously for alcohol or cannabis use disorder
8. Use of cannabis, on average, more than 2 times/week over past 3 months
9. Liver function tests more than 2x normal range
10. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
11. Shipley vocabulary score <18 (corresponds to 5th grade reading level).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 7 patient groups, including a placebo group

Placebo cannabis + placebo alcohol

Placebo Comparator group

Description:

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

Treatment:

Drug: Alcohol

Drug: Cannabis

low dose cannabis with placebo alcohol

Experimental group

Description:

Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.

Treatment:

Drug: Alcohol

Drug: Cannabis

high dose cannabis with placebo alcohol

Experimental group

Description:

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

Treatment:

Drug: Alcohol

Drug: Cannabis

low dose cannabis with low dose alcohol

Experimental group

Description:

Participants administer oral cannabis containing 10mg 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 oral 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 oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).

Treatment:

Drug: Alcohol

Drug: Cannabis

Placebo cannabis + high dose alcohol

Experimental group

Description:

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

Treatment:

Drug: Alcohol

Drug: Cannabis