Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Cannabis
  Cannabis will be vaporized using the Mighty Medic
• Препарат Alcohol
  Alcohol will be orally ingested via a flavored drink
• Препарат Placebo Cannabis
  Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
• Препарат Placebo Alcohol
  A non-alcoholic, placebo, flavored drink will be orally ingested.

Первичные конечные точки

• DRUID application global impairment score [Срок оценки: Up to 6 hours]
• Correct Trials on Paced Auditory Serial Addition Task (PASAT) [Срок оценки: Up to 6 hours]
• Correct Trials on the Digit Symbol Substitution Task (DSST) [Срок оценки: Up to 6 hours]
• Cumulative score on Field Sobriety Tests [Срок оценки: Up to 6 hours]
• Drug Effect Questionnaire (DEQ) - Feel Drug Effect [Срок оценки: Up to 6 hours]
• Drug Effect Questionnaire (DEQ) - Feel High [Срок оценки: Up to 6 hours]
• Drug Effect Questionnaire (DEQ) - Confidence to Drive [Срок оценки: Up to 6 hours]
• Drug Effect Questionnaire (DEQ) - Willingness to Drive [Срок оценки: Up to 6 hours]
• Biphasic alcohol effects scale (BAES) - Sedative Score [Срок оценки: Up to 6 hours]
• Biphasic alcohol effects scale (BAES) - Stimulant Score [Срок оценки: Up to 6 hours]

Вторичные конечные точки (12)

• Driving performance as assessed by standard deviation of speed (SDSP) [Срок оценки: Up to 6 hours]
• Driving performance (mean speed) [Срок оценки: Up to 6 hours]
• Driving performance (number of speed exceedances) [Срок оценки: Up to 6 hours]
• Driving performance (number of accidents) [Срок оценки: Up to 6 hours]
• Driving performance (total rule violations) [Срок оценки: Up to 6 hours]
• Driving performance (distance to lead vehicles) [Срок оценки: Up to 6 hours]
• Attempted Trials on the Digit Symbol Substitution Task (DSST) [Срок оценки: Up to 6 hours]
• Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST) [Срок оценки: Up to 6 hours]
• Reaction time on Paced Auditory Serial Addition Task [Срок оценки: Up to 6 hours]
• Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test [Срок оценки: Up to 6 hours]
• Field Sobriety Test - Score on Walk and Turn test [Срок оценки: Up to 6 hours]
• Field Sobriety Test - Score on One Leg Stand [Срок оценки: Up to 6 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore

Идентификаторы

NCT: NCT06293040 · IRB00434441 · R01DA052295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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