Methylphenidate for Cocaine Dependence

NCT03090269 | Withdrawn Phase 2 DMC

• 2 other identifiers: ANRS STIMAGO2013-002996-16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance-Related Disorders

Keywords

cocaine; methylphenidate; psychostimulant; ADHD; effective dose; pharmacokinetics; crack

Outcome Measures

Primary Outcomes (1)

• Cocaine use

  Difference between weekly cocaine use at M0 and M3 based on the patient self-reports and urinalysis

  Evaluated through the study: during the titration phase (day 1, day 4, day 8, day 11, day 15, day 18) and then at the week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11 and week 12

Secondary Outcomes (9)

• Side effects using the Drug Effects questionnaire (DEQ)

  Evaluated at the week 1, week 2, week 4, week 9 and week 12

• Craving using the Cocaine Craving Questionnaire (CCQ 10-item)

  Evaluated during the titration phase (day 1, day 4, day 8, day 11, day 15, day 18) and then at each visit of the two last months (1 visit a week for 2 months)

• Abstinence (urinalysis)

  Evaluated during the titration phase (day 1, day 8, day 15, day 18) and then at the week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11 and week 12

• Risk practices using the Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)

  Evaluated at the week 1, week 4, week 9 and week 12

• Psychiatric symptoms - Depression using the Center for Epidemiologic Studies - Depression Scale (CES-D)

  Evaluated at the week 1, week 4, week 9 and week 12

Study Arms (1)

Methylphenidate pill

EXPERIMENTAL

18 mg tablets with a 3-week titration phase to a maximum dose of 108 mg per day, orally Associated with phone interviews every month, urine drug toxicologies and blood sampling (PK/PD)

Drug: Methylphenidate Pill

Interventions

Methylphenidate Pill DRUG

3-month follow-up to study the effective dose as a treatment for cocaine dependence in toxicity and reduction in cocaine use

Also known as: Concerta

Methylphenidate pill

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Hopital Paul Brousse: collaborator

Study Sites (1)

Hôpital Paul Brousse

Villejuif, 94800, France

Location

Related Links

• Sponsor of the study

MeSH Terms

Conditions

Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amine Benyamina, Pr

  Hôpital Paul Brousse APHP - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: open-label, single site, national, pilot study, non-comparative before/after

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 24, 2017
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 30, 2019
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)