COMPLETED

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

Official Title

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

Quick Facts

Study Start:2022-02-17

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04931095

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 to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

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 Date2022-02-17

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-02-17

Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

Cannabis Intoxication
Alcohol Intoxication