NCT06081218

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
May 2024Dec 2029

First Submitted

Initial submission to the registry

July 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 13, 2025

Status Verified

January 1, 2025

Enrollment Period

5.1 years

First QC Date

July 6, 2023

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma endocannabinoids levels (pmol/ml)

    2 weeks

Secondary Outcomes (5)

  • regulating hormone of endocannabinoids (plasma levels of cortisol, ng/ml)

    2 weeks

  • Blood marker of neurogenesis and neuroplasticity (plasma levels and BDNF, pg/ml)

    2 weeks

  • change in cerebral muscular, oxygenation (HHB), (HbO2), (Hbtot) (arbitrary unit)

    2 weeks

  • Cognitive function (selective attention, stroop test)

    2 weeks

  • Oxygen consumption (VO2) (ml/min/kg)

    2 weeks

Study Arms (2)

Chronic cannabis users

EXPERIMENTAL
Other: activity test

Healthy subjects

SHAM COMPARATOR
Other: activity test

Interventions

Over 2 weeks, participants have to do a maximal progressive exercise and a 30 min constant exercise at 50% of maximal aerobic power

Chronic cannabis usersHealthy subjects

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 CAST.
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Lille

Lille, 59000, France

RECRUITING

MeSH Terms

Interventions

Carcinogenicity Tests

Intervention Hierarchy (Ancestors)

Toxicity TestsInvestigative Techniques

Central Study Contacts

Olivier Cottencin, MD,PhD

CONTACT

Francois-xavier Gamelin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

October 13, 2023

Study Start

May 7, 2024

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 13, 2025

Record last verified: 2025-01

Locations