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Trial record 10 of 621 for:    Recruiting, Not yet recruiting, Available Studies | "Substance-Related Disorders"

Methylphenidate for Cocaine Dependence (ANRS STIMAGO)

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ClinicalTrials.gov Identifier: NCT03090269
Recruitment Status : Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Hopital Paul Brousse
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: Methylphenidate Pill Phase 2

Detailed Description:

Patients will receive pharmacotherapy based on methylphenidate (18 mg per tablet) with a 3-week titration phase to a maximum dose of 108 mg per day, with a weekly follow-up during 3 months. Socio-demographic and behavioral data will be collected through phone interviews every month. During medical visits, self-administered and clinical questionnaires will collect clinical and behavioral data. Urine drug toxicologies and blood sampling will be performed to gather biological, pharmacokinetic and pharmacodynamic data.

This study should identify an effective response-dose of methylphenidate for people with a cocaine use disorder. The methylphenidate should be effective to reduce cocaine use in cocaine-dependent individuals with a good tolerability. The results of pharmacokinetic and pharmacodynamic analyses will give us the effective dose of methylphenidate and some information on toxicity to adapt the surveillance in a future clinical trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, single site, national, pilot study, non-comparative before/after
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Experimental: Methylphenidate pill

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




Primary Outcome Measures :
  1. Cocaine use [ Time Frame: 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 ]
    Difference between weekly cocaine use at M0 and M3 based on the patient self-reports and urinalysis


Secondary Outcome Measures :
  1. Side effects using the Drug Effects questionnaire (DEQ) [ Time Frame: Evaluated at the week 1, week 2, week 4, week 9 and week 12 ]
    Number of perceived side effects of methylphenidate with the Drug Effects questionnaire (DEQ)

  2. Craving using the Cocaine Craving Questionnaire (CCQ 10-item) [ Time Frame: 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) ]
    Cocaine craving with the Cocaine Craving Questionnaire (CCQ 10-item)

  3. Abstinence (urinalysis) [ Time Frame: 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 ]
    Cocaine abstinence with urinalysis

  4. Risk practices using the Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ) [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Reduction in Hepatitis C (HCV) risk practices, unsafe sex, sharing syringes - Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)

  5. Psychiatric symptoms - Depression using the Center for Epidemiologic Studies - Depression Scale (CES-D) [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Reduction in psychiatric symptoms with the Center for Epidemiologic Studies - Depression Scale (CES-D)

  6. Psychiatric symptoms - Attention/Deficit using the attention-deficit/hyperactivity disorder Scale (ADHD) [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Reduction in psychiatric symptoms with the attention-deficit/hyperactivity disorder Scale (ADHD)

  7. Psychiatric symptoms - Sensation Seeking using the 6-item Sensation Seeking Scale (SSQ 6-item) [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Reduction in psychiatric symptoms with the 6-item Sensation Seeking Scale (SSQ 6-item)

  8. Criminal behaviors [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Reduction in self-reported criminal behaviors by questionnaire

  9. Quality of life using the the 12-Item Short Form Health Survey (SF-12) [ Time Frame: Evaluated at the week 1, week 4, week 9 and week 12 ]
    Increase of quality of life score with the 12-Item Short Form Health Survey (SF-12)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090269


Contacts
Contact: Perrine Roux, DR +33413732278 perrine.roux@inserm.fr
Contact: Gwenaëlle Maradan +33413732255 gwenaelle.maradan@inserm.fr

Locations
France
Hôpital Paul Brousse Not yet recruiting
Villejuif, France, 94800
Principal Investigator: Amine Benyamina, Pr         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Hopital Paul Brousse
Investigators
Principal Investigator: Amine Benyamina, Pr Hôpital Paul Brousse APHP - France

Additional Information:
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03090269     History of Changes
Other Study ID Numbers: ANRS STIMAGO
2013-002996-16 ( EudraCT Number )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
cocaine
methylphenidate
psychostimulant
ADHD
effective dose
pharmacokinetics
crack

Additional relevant MeSH terms:
Substance-Related Disorders
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methylphenidate
Cocaine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents