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Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users (CANNABEX)

Primary Purpose

Cannabis User

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
activity test
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis User

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cannabis consumer group: Cannabis consumption > 100 times in lifetime, last exposure < 7 days, and recent exposure > 10 times in the month. Positive toxicological urine test for ∆-9-THC. Having a cannabis use disorder according to the DSM-5 (cannabis abuse disorder). Healthy group: Negative urine toxicological test for cannabis. No regular cannabis use for more than 6 months once in a lifetime. No cannabis consumption in the 6 months preceding the study. Exclusion Criteria: For all subjects : Disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs). Alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit. Under medical treatment. Presence of diagnosed neurological disorders. Diagnosis of a psychotic picture entering axis I, DSM-5. Chronic progressive disease or in remission. Body mass index > 30 kg/m2 (i.e. presence of obesity).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Chronic cannabis users

    Healthy subjects

    Arm Description

    Outcomes

    Primary Outcome Measures

    Plasma endocannabinoids levels (pmol/ml)

    Secondary Outcome Measures

    regulating hormone of endocannabinoids (plasma levels of cortisol, ng/ml)
    Blood marker of neurogenesis and neuroplasticity (plasma levels and BDNF, pg/ml)
    change in cerebral muscular, oxygenation (HHB), (HbO2), (Hbtot) (arbitrary unit)
    Cognitive function (selective attention, stroop test)
    The stroop test can be used to measure a person's selective attention capacity
    Oxygen consumption (VO2) (ml/min/kg)

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06081218
    Brief Title
    Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users
    Acronym
    CANNABEX
    Official Title
    Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The endocannabinoid system (ECS) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (CB1 and CB2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - eCBs), and enzymes for ligand biosynthesis and degradation. Interestingly, exercise increase plasma AEA, one of the most famous endocannabinoid. This increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. Chronic cannabis use is associated with alteration of ECS activity. The aim of the study is to compare ECS response to exercise between chronic cannabis users and non-users.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis User

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chronic cannabis users
    Arm Type
    Experimental
    Arm Title
    Healthy subjects
    Arm Type
    Sham Comparator
    Intervention Type
    Other
    Intervention Name(s)
    activity test
    Intervention Description
    Over 2 weeks, participants have to do a maximal progressive exercise and a 30 min constant exercise at 50% of maximal aerobic power
    Primary Outcome Measure Information:
    Title
    Plasma endocannabinoids levels (pmol/ml)
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    regulating hormone of endocannabinoids (plasma levels of cortisol, ng/ml)
    Time Frame
    2 weeks
    Title
    Blood marker of neurogenesis and neuroplasticity (plasma levels and BDNF, pg/ml)
    Time Frame
    2 weeks
    Title
    change in cerebral muscular, oxygenation (HHB), (HbO2), (Hbtot) (arbitrary unit)
    Time Frame
    2 weeks
    Title
    Cognitive function (selective attention, stroop test)
    Description
    The stroop test can be used to measure a person's selective attention capacity
    Time Frame
    2 weeks
    Title
    Oxygen consumption (VO2) (ml/min/kg)
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Cannabis consumer group: Cannabis consumption > 100 times in lifetime, last exposure < 7 days, and recent exposure > 10 times in the month. Positive toxicological urine test for ∆-9-THC. Having a cannabis use disorder according to the DSM-5 (cannabis abuse disorder). Healthy group: Negative urine toxicological test for cannabis. No regular cannabis use for more than 6 months once in a lifetime. No cannabis consumption in the 6 months preceding the study. Exclusion Criteria: For all subjects : Disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs). Alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit. Under medical treatment. Presence of diagnosed neurological disorders. Diagnosis of a psychotic picture entering axis I, DSM-5. Chronic progressive disease or in remission. Body mass index > 30 kg/m2 (i.e. presence of obesity).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier Cottencin, MD,PhD
    Phone
    0320445962
    Email
    olivier.cottencin@chru-lille.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francois-xavier Gamelin, PhD
    Email
    francois-xavier.gamelin@univ-lille.fr

    12. IPD Sharing Statement

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    Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users

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