Cocaine addiction MedDRA version: 20.1 Level: LLT Classification code 10009817 Term: Cocaine dependence System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Lysomucil 600 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: acétylcystéine
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Centre Hospitalier Universitaire Brugmann
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients diagnosed with cocaine dependence according to the DSM V (statistical and diagnostic manual of mental disorders, 5th revision) - Patients performing a 3-week detoxication cure within the Unit 73 of the Brugmann Hospital - French speaking patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Anti-craving medication intake - Antipsychotics intake - Other dependence diagnosed (excluding tobacco and cannabis) - History of neurological disorders - History of psychiatric disorders that may hinder the smooth running of the experiment - Other serious medical conditions (according to the investigator's judgment) - Asthma - Pregnancy - Lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the intensity of craving of the patients ;Secondary Objective: - test the evolution of the craving according to time - measure the relapse rate - measure the duration of time before relapse;Primary end point(s): - Likert scale results - CCQ Brief questionnaire results;Timepoint(s) of evaluation of this end point: - Likert scale: day one (baseline) and day 5 - CCQ Brief questionnaire : dailyup to day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - CCQ Brief questionnaire results - Number of days between the first intake of acetylcysteine or lactose and relapse.;Timepoint(s) of evaluation of this end point: - Once per week, up to one month after acetylcysteine or lactose intake. | — |
Countries
Belgium
Contacts
Public ContactSalvatore Campanella
Centre Hospitalier Universitaire Brugmann
Outcome results
None listed