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

NCT02134002 | Withdrawn Phase 4

• 1 other identifier: P121006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence

Keywords

cocaine; disulfiram; beta-dopamine hydroxylase

Outcome Measures

Primary Outcomes (1)

• Variations in linkage rates of 11Craclopride in the nucleus accumbens between baseline TEP measurement and TEP measurement following administration of 20 mg of methylphenidate.

  The primary objective of this trial is to show that in abstinent cocaine patients, DBH inhibition by disulfiram induces reduced dopaminergic response following methylphenidate administration.

  up to 15 days after randomization

Secondary Outcomes (3)

• DBH activity as measured directly, and indirectly by the DHPG / DOPAC report.

  Before and after stimulation by methylphenidate, 8 to 15 days after randomization.

• Measurement of craving in cocaine by a simple Likert scale.

  Before and after stimulation by methylphenidate, 8 to 15 days after randomization.

• Measure of aversion to cocaine by a simple Likert scale.

  before and after stimulation by methylphenidate, 8 to 15 days after randomization.

Study Arms (2)

Disulfiram

EXPERIMENTAL

disulfiram 250 mg/day

Drug: Disulfiram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Disulfiram DRUG

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.

Disulfiram

Placebo DRUG

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.

Also known as: Placebo of disulfiram

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Research Agency, France: collaborator

Study Sites (1)

Paul Brousse Hospital

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Henri-Jean AUBIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 8, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

FR (1)