Cocaine dependence MedDRA version: 18.0 Level: LLT Classification code 10009817 Term: Cocaine dependence System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Concerta LP 18 mg
Pharmaceutical Form: Prolonged-release tablet
Sponsors
Inserm-ANRS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged between 18 and 64 years old. • Diagnosed with cocaine/crack dependence using DSM IV (and CIM 10) and willing to be abstinent. • Having a cocaine/crack positive urinary test. • Willing to participate. • Being able to give consent 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Dependence on alcohol and/or other substances. • Hypersensitivity to the active compound methylphenidate or to filler. • Glaucoma. • Phaeochromocytoma • Family history or diagnosis of Gilles de la Tourette syndrome. • During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors. • History of hyperthyroidism or of thyrotoxicosis. • Preexisting cardiovascular problems including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrythmias and channelopathies, (disorders caused by the dysfunction of ionic channels). • Preexisting cerebrovascular disorders, cerebral aneurism, vascular abnormalities including vasculitis or stroke. • Diagnosis or history of severe depression, anorexia nervosa or anorexic disorders. • Suicidal tendencies or characterized suicidal syndrome. • Pregnancy, breast-feeding or absence of any contraception for female participants. • Unstabilized psychiatric comorbidity likely to compromise adherence to treatment. • Comorbidity or handicap likely to corrupt evaluation. Organic pathology severe enough according to the investigator, likely to comprise adequate surveillance during the trial. • Patient about to leave the area for a period of time preventing his/her adequate participation in the trial. • Insufficient motivation. • Participation in another clinical trial with an on-going exclusion period at the time of the pre-inclusion visit. • Lack of medical insurance. • Unreachable by phone. • Patient on mandatory treatment. • Patient with legal incapacity (under guardianship/curatorship). • Patient kept in detention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effective dose of a psycho-stimulant, methylphenidate, as a treatment for cocaine dependence in terms of risks/benefits (toxicity and reduction in cocaine use).;Primary end point(s): • Difference between weekly cocaine use at M0 and M3.;Timepoint(s) of evaluation of this end point: • Cocaine use at Month 3 ; Secondary Objective: - To measure cocaine abstinence 3 months after initiation of treatment. - To measure the reduction of HCV risk practices, subjective effects of treatment, craving, psychiatric comorbidities (depression and ADHD), criminal acts, quality of life, social reinsertion, access to care… | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of perceived side effects. Craving, Cocaine abstinence ; Reduction in HCV risk practices ; Reduction in psychiatric symptoms (score CES-D, score ADHD) : Reduction in criminal behaviors ; Increase of quality of life score ; Increase of socio-professional reinsertion level. ;Timepoint(s) of evaluation of this end point: Evaluation at M1, M2 and M3 | — |
Countries
France
Contacts
Public ContactPerrine Roux
Inserm U912
Outcome results
None listed