NCT01793961

Brief Summary

Rates of driving under the influence of cannabis have risen in recent years. Cannabis is involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. The investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be compared to standard references. In addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity. In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. The investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. The investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

February 12, 2013

Last Update Submit

July 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The contrast detection treshold

    Comparison of the contrast detection threshold of the 3 groups

    up to 9 days after inclusion

Study Arms (3)

"Cannabis" Arm

OTHER

patient addicted to cannabis

Other: electroretinogramOther: contrast sensitivity tests

"Tobacco" Arm

OTHER

patient addicted to tobacco

Other: electroretinogramOther: contrast sensitivity tests

"Healthy volunteers"

OTHER

no smokers

Other: electroretinogramOther: contrast sensitivity tests

Interventions

"Cannabis" Arm"Healthy volunteers""Tobacco" Arm
"Cannabis" Arm"Healthy volunteers""Tobacco" Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • "Cannabis" Arm
  • patient addicted to cannabis
  • Positive CAST test result
  • Urine tested positive for cannabis metabolites
  • "Tobacco" Arm
  • positive Fagerström test result
  • No previous history of cannabis use
  • "Healthy Volunteers"
  • No history of addictive disorders

You may not qualify if:

  • addiction to other substances than cannabis or tobacco
  • benzodiazepine treatment
  • patient with history of benzodiazepine treatment
  • patient with history of head trauma
  • Pregnant woman
  • breast feeding woman
  • Adults under supervision or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

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

February 12, 2013

First Posted

February 18, 2013

Study Start

March 22, 2013

Primary Completion

November 30, 2015

Study Completion

September 10, 2018

Last Updated

July 12, 2019

Record last verified: 2019-07