Brain Activity Under the Influence of JWH
- Conditions
- Neurotransmission During JWH Intoxication
- Interventions
- Other: non-active control (no substance)
- Registration Number
- NCT06044415
- Lead Sponsor
- Maastricht University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description JWH-018 condition JWH018 - Placebo condition non-active control (no substance) -
- Primary Outcome Measures
Name Time Method Neurotransmission up to 3.5 hours after drug administration neurochemical concentration of glutamate, GABA and dopamine measured with MRS and resting-state fMRI
Functional connectivity during acute intoxication Functional connectivity strength as measured by resting-state fMRI
- Secondary Outcome Measures
Name Time Method sustained attention up to 3.5 hours after intoxication Psychomotor Vigilance Task: reaction time and attentional lapses are measured.
attentional salience processing up to 3.5 hours after intoxication visual oddball paradigm: neural response to oddball vs standard stimuli presentation, reaction time is measured.
Subjective drug effects - drug liking up to 3.5 hours after intoxication Sensitivity to Cannabis Reinforcement Questionnaire, scored on a 5 point scale (1= somewhat to 5 = extremely).
Subjective drug effects - subjective high up to 3.5 hours after intoxication will be self-rated on a 10 cm visual analogue scale. Higher values mean more intense effects.
false memory formation up to 3.5 hours after intoxication Deese-Roediger-McDermott paradigm, true and false recognition scores are obtained and confidence ratings.
Subjective drug effects - dissociative state up to 3.5 hours after intoxication Clinician Administered Dissociative States Scale rated on a 5 point scale. Higher values mean a more intense effect.
Subjective drug effects - psychedelic-like effects up to 3.5 hours after intoxication Will be assessed using a 10cm Bowdles Visual Analogue Scale with 13 items. Higher values mean more intense effects.
Subjective drug effects - Altered States of Consciousness Rating Scale (5D-ASC) up to 3.5 hours after intoxication as rated on 10cm Visual Analogue Scales. Higher values mean more intense effects.
Subjective drug effects - psychosis-like effects up to 3.5 hours after intoxication Based on the investigator-rated semi-structured interview "Positive and negative syndrome scale - positive subscale", psychosis-like symptoms are rated between 1 (absent) and 7 (extreme).
Subjective drug effects - retrospective drug reinforcement (RDRV) up to 3.5 hours after intoxication Self-rated questionnaire to assess tolerability and reinforcing properties. The subject has to score 1) the overall experience on a visual analog scale \[VAS\] (0 = intolerable to 100: well-tolerated), 2) the likelihood of using the drug again (0= not at all to 100= most of all), 3) how much they are willing to pay for the experience (€0 to €100) and 4) how likely they are to choose this over cannabis (0= not at all to 100= extremely).
JWH-018 kinetics baseline & regular intervals up to 3.5 hours after intoxication JWH-018 concentration in serum
Metabolomics baseline & regular intervals up to 3.5 hours after intoxication metabolomic concentration in serum
Inflammatory cytokines at baseline & within 30 minutes after intoxication cytokines IL-6, TNF-alpha, and C-reactive protein concentration in serum