A PET Exploration of the Mechanism of Action of Dopamine Beta-hydroxylase Inhibition in Cocaine Addicts

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study represents a randomized, double blind placebo-controlled trial. Thirty cocaine dependant patients will be included in this study during their hospitalization for withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250 mg/day or placebo over the 15 days of their hospitalization. Main outcome criteria will be evaluated during two TEP imaging sessions with 11Craclopride, before and after stimulation by methylphenidate, 8 to 15 days after randomization.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: National Research Agency, France
• Treatments: Cocaine; Disulfiram; Dopamine; Dopamine Agents

Criteria

Inclusion Criteria:

• men aged 18 years ans less than or equal 65

• diagnosis of cocaine dependence according to DSM IV

• hospitalization for cocaine withdrawal

• ability to understand and give informed consent orally ans in writing

• affiliation to a social security

• patient with a normal ECG and normal blood pressure

Exclusion Criteria:

• Psychiatric comorbidity : psychotic disorder, manic episode , major depressive current , high suicide risk , assessed by structured interview of the Mini International Neuropsychiatric Interview

• Neurological histories: neurological deficit focused, organic cerebral disorder , epilepsy, dementia

• Severe hepatic insufficiency

• Severe renal insufficiency

• Severe respiratory

• Diabetes

• Hypersensitivity disulfiram or any of the other components

• Neuropsychological disorder

• Preexisting cardiovascular disorders

• Hypersensitivity to methylphenidate or any of the excipients

• Hyperthyroidism or thyrotoxicosis

• Glaucoma

• Pheochromocytoma

• Preexisting cerebrovascular disorders

• Patient presenting an allergy to the wheat

• HIV or HCV seropositivity

• Family or personal history of motor tics, and syndrome of Gilles Tourette

• Any disorder that may interfere with adherence to treatment

• Pharmacological treatment interfering with catecholamines

• Participation in another clinical trial or exclusion period of a previous clinical trial

• Contraindications to magnetic resonance imaging

• People under placement measure

• Hypersensitivity to any component of NIQUITIN

• Skin disorder that may interfere with the use of a transdermal patch

• Patient under treatment with irreversible inhibitors of mono- amine oxidase inhibitors (MAOIs ) , and for at least 14 days following the stop of the treatment by an IMAO.

• Diagnosis or history of bipolar disorders (affective ) episodic and severe ( type 1 )"