Substance-Related DisordersPhase 2ANRS STIMAGONCT03090269
Methylphenidate for Cocaine Dependence
A Phase 2 study testing Methylphenidate Pill in people with Substance-Related Disorders, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Methylphenidate Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 30 Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Methylphenidate Pill
- Keywords
- cocaine, methylphenidate, psychostimulant, ADHD, effective dose, pharmacokinetics, crack
- Medical subject headings
- Substance-Related Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate PillDrug
Also called Concerta
3-month follow-up to study the effective dose as a treatment for cocaine dependence in toxicity and reduction in cocaine use
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Methylphenidate Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Difference between weekly cocaine use at M0 and M3 based on the patient self-reports and urinalysis
Measured: 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)
Number of perceived side effects of methylphenidate with the Drug Effects questionnaire (DEQ)
Measured: Evaluated at the week 1, week 2, week 4, week 9 and week 12
Craving using the Cocaine Craving Questionnaire (CCQ 10-item)
Cocaine craving with the Cocaine Craving Questionnaire (CCQ 10-item)
Measured: 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)
Cocaine abstinence with urinalysis
Measured: 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)
Reduction in Hepatitis C (HCV) risk practices, unsafe sex, sharing syringes - Blood Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)
Measured: 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)
Reduction in psychiatric symptoms with the Center for Epidemiologic Studies - Depression Scale (CES-D)
Measured: Evaluated at the week 1, week 4, week 9 and week 12
Psychiatric symptoms - Attention/Deficit using the attention-deficit/hyperactivity disorder Scale (ADHD)
Reduction in psychiatric symptoms with the attention-deficit/hyperactivity disorder Scale (ADHD)
Measured: Evaluated at the week 1, week 4, week 9 and week 12
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)
Measured: Evaluated at the week 1, week 4, week 9 and week 12
Criminal behaviors
Reduction in self-reported criminal behaviors by questionnaire
Measured: Evaluated at the week 1, week 4, week 9 and week 12
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)
Measured: Evaluated at the week 1, week 4, week 9 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Mar 2019 (estimated)
Why it stopped: feasibility reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, single site, national, pilot study, non-comparative before/after
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Hopital Paul Brousse
- Responsible party
- Sponsor
- Investigators
- Amine Benyamina, Pr, Principal investigator, Hôpital Paul Brousse APHP - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090269
- Sponsor's protocol ID
- ANRS STIMAGO
- Other IDs
- 2013-002996-16
- Acronym
- ANRS STIMAGO
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT03090269
- Acronym / sponsor ID
- ANRS STIMAGO / ANRS STIMAGO
- Conditions
- Substance-Related Disorders
- Keywords
- cocaine, methylphenidate, psychostimulant, ADHD, effective dose, pharmacokinetics, crack
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: feasibility reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Hopital Paul Brousse
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, single site, national, pilot study, non-comparative before/after
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate pill | Experimental | Drug: Methylphenidate Pill18 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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate PillAlso: Concerta3-month follow-up to study the effective dose as a treatment for cocaine dependence in toxicity and reduction in cocaine use | Drug | Methylphenidate pill |
Primary outcome
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
9 secondary outcomes
Side effects using the Drug Effects questionnaire (DEQ)
Time frame: Evaluated at the week 1, week 2, week 4, week 9 and week 12
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)
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
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
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
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
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
Criminal behaviors
Time frame: Evaluated at the week 1, week 4, week 9 and week 12
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Sponsor of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine Benyamina, Pr principal investigator
Hôpital Paul Brousse APHP - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate Pill in people with Substance-Related Disorders, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.