Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2016-002547-42

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

Bristol Imperial MDMA in Alcoholism Study (BIMA)

A.4.1

Sponsor's protocol code number

BIMA2016

A.5.4

Other Identifiers

Name:	REC	Number:	16/SW/0273
Name:	Sponsor	Number:	16HH3426
Name:	R&D	Number:	957AWP

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Imperial College London, Joint Research Compliance Office
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	The Alexander Mosley Charitable Trust
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Imperial College London
B.5.2	Functional name of contact point	David Nutt
B.5.3	Address:
B.5.3.1	Street Address	Imperial College London Burlington Danes Building Hammersmith Hospital campus 160 Du Cane Road
B.5.3.2	Town/ city	London
B.5.3.3	Post code	W12 0NN
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	02075946628
B.5.6	E-mail	d.nutt@imperial.ac.uk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	3,4-methylenedioxmethamphetamine (MDMA)
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	3,4-methylenedioxymethamphetamine
D.3.9.1	CAS number	CAS-42542-10
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	62.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Alcohol Use Disorder

E.1.1.1

Medical condition in easily understood language

Alcohol Dependence or Alcoholism

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10001594
E.1.2	Term	Alcohol dependence syndrome
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

These outcome measures will be assessed during and at the end of the treatment period.

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1