Methylphenidate for Cocaine Dependence

• Status: Withdrawn
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use reduction and adverse events.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Hopital Paul Brousse
• Treatments: Cocaine; Methylphenidate

Criteria

Inclusion Criteria:

• Diagnosed with cocaine/crack/amphetamine derivate dependence using Diagnostic and Statistical Manual of Mental Disorders (DSM V) (and International Classification of Diseases (ICD 10)) and willing to be abstinent.

• Having a cocaine/crack positive urinary test.

• Effective contraception for women of childbearing age.

• Willing to participate.

• Registered at social insurance/security.

• Being able to give consent.

• Reachable by telephone.

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/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder

• Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)

• 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 or curatorship)