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    Summary
    EudraCT Number:2016-002547-42
    Sponsor's Protocol Code Number:BIMA2016
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-002547-42
    A.3Full title of the trial
    Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients with Alcohol Use Disorder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploring MDMA in psychotherapy in detoxified patients with alcohol dependency syndrome.
    A.3.2Name or abbreviated title of the trial where available
    Bristol Imperial MDMA in Alcoholism Study (BIMA)
    A.4.1Sponsor's protocol code numberBIMA2016
    A.5.4Other Identifiers
    Name:RECNumber:16/SW/0273
    Name:SponsorNumber:16HH3426
    Name:R&DNumber:957AWP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImperial College London, Joint Research Compliance Office
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Alexander Mosley Charitable Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointDavid Nutt
    B.5.3 Address:
    B.5.3.1Street AddressImperial College London Burlington Danes Building Hammersmith Hospital campus 160 Du Cane Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0NN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02075946628
    B.5.6E-maild.nutt@imperial.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name3,4-methylenedioxmethamphetamine (MDMA)
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN3,4-methylenedioxymethamphetamine
    D.3.9.1CAS number CAS-42542-10
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alcohol Use Disorder
    E.1.1.1Medical condition in easily understood language
    Alcohol Dependence or Alcoholism
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a proof of concept feasibility study assessing if MDMA-Assisted Psychotherapy can be delivered safely, and is tolerated and acceptable to patients with alcohol use disorder who have recently been detoxified from alcohol.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of MDMA-assisted psychotherapy on drinking behaviour, psychosocial functioning and quality of life.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Informed consent
    • Primary diagnosis (as defined by DSM-5) of alcohol use disorder.
    • Successful alcohol detoxification (no longer consuming any alcoholic substances).
    • Between 18 and 65 years old.
    • Be able to identify in advance a supportive significant other(s):
    -who could accompany the patient to study visits if required and provide supervision after drug-assisted sessions.
    -who can be contacted by the study team in order to remind the patient about follow-up appointments or collect outcome data (such as drinking behaviour) in the event that the patient themselves cannot be contacted.
    • Proficient in speaking and reading English.
    • Agree to comply with requirements of protocol.
    E.4Principal exclusion criteria
    • Lacking capacity
    • History of, or a current, primary psychotic disorder, bipolar affective disorder type 1 or personality disorder;
    • Present a serious suicide risk;
    • Relevant abnormal clinical findings at screening visit judged by the investigator to render subject unsuitable for study. Including but not limited to:
    o History of cardiac disease, hypertension and stroke
    o History of severe liver disease, as evidenced by abnormal liver function test results, particularly reduction in albumin (normal > to 3.5 gm/dl).
    o History of epilepsy;
    o History of Malignant Hyperthermia (Central Core Disease);
    • Regular user of Ecstasy (material represented as containing MDMA). E.g. more than five times in the last five years or at least twice in the 6 months prior to the start of the study;
    • Currently taking or unwilling/unable to stop any medications inhibiting CYP 2D6, and the following medications Monoamine Oxidase Inhibitors, Ritonavir (HIV treatment), paroxetine, fluoxetine, citalopram, regular benzodiazepines or any other medications likely to interact with MDMA the opinion of the investigators, during 8 week MDMA assisted therapy only
    • Regular use of/dependence on other drugs such as benzodiazepines, synthetic cannabinoids, cocaine and heroin.
    • For females of childbearing age/potential (during 8 week MDMA assisted therapy only):
    o Must use an effective form of birth control during the study.
    o Must not be breast-feeding.
    • Taken part in a study involving an investigational product in the last three months

    E.5 End points
    E.5.1Primary end point(s)
    This is proof of concept open label, feasibility study exploring the tolerability, acceptability and use of MDMA-assisted psychotherapy.

    The main outcome measure for this study will be safety and tolerability as measured by:
    • Any adverse events during the treatment period
    • Number of patients completing 8-week course of MDMA-assisted psychotherapy.
    • Number of patients accepting second booster dose of MDMA during drug-assisted psychotherapy sessions.


    E.5.1.1Timepoint(s) of evaluation of this end point
    These outcome measures will be assessed during and at the end of the treatment period.
    E.5.2Secondary end point(s)
    During the course of 8-week therapy:

    • Intensity of MDMA drug effect on dosing days (VAS/SUDS)
    • Subjective sleep rating the night following dosing (Leeds Evaluation Questionnaire).
    • Mood ratings over 5 days following MDMA; (Positive and Negative Affect Scale).
    • At the end of the 8 weeks: acceptability of MDMA-Assisted therapy program

    At 3*, 6* and 9* months, the following will be assessed, using standardised scales, the Time Line Follow-Back drink diary method and clinical interview, supported by monthly phone calls;

    • Drinking behaviour (where Day 0 = completion of the detoxification program), specifically:
    • Number of cumulative non-drink days
    • Rate of complete abstinence from alcohol
    • Quantity of alcohol consumed on drinking days (if drinking)
    • Number and % of heavy drinking days compared to baseline (if drinking)
    • Quality of life, including subjective sleep
    • Psychosocial functioning
    • Prescribed medication use
    • Number and frequency of recreational drugs (if any)
    • Craving relating to MDMA and any subsequent use of illicit ecstasy.
    • Assessment of ability to collect follow-up data (ease of contacting patients/ number of calls made etc.).

    *As this is a feasibility study we will assess the success of collecting information at follow up. It may not be possible to contact all patients at all time points, especially at 9 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These outcome measures will be assessed during and at the end of the treatment period, and for follow-up measures at 3,6 and 9 months as stated above and in the protocol.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention can only be made available during the trial and not thereafter. Beyond participation in this study, patients will be receive treatment as usual, directed by their care team.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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