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Methylphenidate for Cocaine Dependence (ANRS STIMAGO)

Primary Purpose

Substance-Related Disorders

Status

Withdrawn

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Methylphenidate Pill

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring cocaine, methylphenidate, psychostimulant, ADHD, effective dose, pharmacokinetics, crack

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Hôpital Paul Brousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylphenidate pill

Arm Description

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)

Outcomes

Primary Outcome Measures

Cocaine use

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

Secondary Outcome Measures

Side effects using the Drug Effects questionnaire (DEQ)

Number of perceived side effects of methylphenidate with the Drug Effects questionnaire (DEQ)

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

Cocaine craving with the Cocaine Craving Questionnaire (CCQ 10-item)

Abstinence (urinalysis)

Cocaine abstinence with urinalysis

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

Reduction in Hepatitis C (HCV) risk practices, unsafe sex, sharing syringes - Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)

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

Reduction in psychiatric symptoms with the Center for Epidemiologic Studies - Depression Scale (CES-D)

Psychiatric symptoms - Attention/Deficit using the attention-deficit/hyperactivity disorder Scale (ADHD)

Reduction in psychiatric symptoms with the attention-deficit/hyperactivity disorder Scale (ADHD)

Psychiatric symptoms - Sensation Seeking using the 6-item Sensation Seeking Scale (SSQ 6-item)

Reduction in psychiatric symptoms with the 6-item Sensation Seeking Scale (SSQ 6-item)

Criminal behaviors

Reduction in self-reported criminal behaviors by questionnaire

Quality of life using the the 12-Item Short Form Health Survey (SF-12)

Increase of quality of life score with the 12-Item Short Form Health Survey (SF-12)

Full Information

NCT ID

NCT03090269

First Posted

March 14, 2017

Last Updated

July 19, 2018

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Hopital Paul Brousse

1. Study Identification

Unique Protocol Identification Number

NCT03090269

Brief Title

Methylphenidate for Cocaine Dependence

Acronym

ANRS STIMAGO

Official Title

Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Withdrawn

Why Stopped

feasibility reasons.

Study Start Date

June 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

March 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Hopital Paul Brousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance-Related Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylphenidate pill

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Methylphenidate Pill

Other Intervention Name(s)

Concerta

Intervention Description

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

Primary Outcome Measure Information:

Title

Cocaine use

Description

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

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

Secondary Outcome Measure Information:

Title

Side effects using the Drug Effects questionnaire (DEQ)

Description

Number of perceived side effects of methylphenidate with the Drug Effects questionnaire (DEQ)

Time Frame

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

Title

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

Description

Cocaine craving with 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)

Title

Abstinence (urinalysis)

Description

Cocaine abstinence with 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

Title

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

Description

Reduction in Hepatitis C (HCV) risk practices, unsafe sex, sharing syringes - Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)

Time Frame