RECRUITING

Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Conditions

Cannabis Intoxication Alcohol Intoxication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-09-26

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06293040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Tory Spindle, PhD

CONTACT

410-550-0529

tspindle@jhmi.edu

Principal Investigator

Tory Spindle, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Tory Spindle, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-26

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Cannabis Intoxication
Alcohol Intoxication