Clinical trial NCT06044415: Brain Activity Under the Influence of JWH
Official title: Brain Kinetics of Neurotransmission During JWH-018 Intoxication
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurotransmission During JWH Intoxication
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this placebo-controlled study is to learn about the neural mechanisms underlying the acute effects of the synthetical cannabinoid JWH-018 in healthy, occasional cannabis users. It aims to assess neural underpinnings of neurocognitive impairments and psychotomimetic symptoms expected during the intoxication. Neuronal changes similar to those seen in cannabis intoxication are expected, such as altered neurotransmission and loss of functional connectivity within the mesocorticolimbic circuit. MRS, fMRI and blood parameters will be used for assessment. Participants will be asked to complete cognitive tasks and subjective questionnaires related to the subjective experience of the drug.


Eligibility criteria: Inclusion Criteria:

* sufficient experience with cannabis
* Age between 18 and 40 years
* Free from psychotropic medication
* Good physical health
* Absence of any major medical, endocrine and neurological condition
* Normal weight, body mass index (weight/height\^2) between 18 and 28 kg/m\^2
* Written Informed Consent
* Good knowledge and understanding of the English language
* refrain from taking illicit psychoactive substances during the study
* willing to drink only alcohol-free liquids and no caffeinated beverages from 24 hours prior to dosing day, as well as during the study day
* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.

Exclusion Criteria:

* History of drug addiction
* Pregnancy or lactation or pregnancy planned during study participation
* Hypertension (diastolic \> 90 mmHg; systolic \> 140 mmHg)
* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
* Any chronic or acute medical condition
* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,...)
* For women: no use of a reliable contraceptive
* Tobacco smoking (\>20 per day)
* Excessive drinking (\>20 alcoholic consumptions per week)
* Simultaneous participation in another clinical trial
* fMRI contraindications

Primary outcomes:
measure: Neurotransmission
timeFrame: up to 3.5 hours after drug administration
measure: Functional connectivity
timeFrame: during acute intoxication
Secondary outcomes:
measure: false memory formation
timeFrame: up to 3.5 hours after intoxication
measure: sustained attention
timeFrame: up to 3.5 hours after intoxication
measure: attentional salience processing
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - drug liking
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - subjective high
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - dissociative state
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - psychedelic-like effects
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - Altered States of Consciousness Rating Scale (5D-ASC)
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - psychosis-like effects
timeFrame: up to 3.5 hours after intoxication
measure: Subjective drug effects - retrospective drug reinforcement (RDRV)
timeFrame: up to 3.5 hours after intoxication
measure: JWH-018 kinetics
timeFrame: baseline & regular intervals up to 3.5 hours after intoxication
measure: Metabolomics
timeFrame: baseline & regular intervals up to 3.5 hours after intoxication
measure: Inflammatory cytokines
timeFrame: at baseline & within 30 minutes after intoxication
Other outcomes:
measure: Blinding quality
timeFrame: at end of each test day (day 1 and 2)
Locations:
Study officials:
References: