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Bristol Imperial MDMA in Alcoholism Study (BIMA)

  • Research type

    Research Study

  • Full title

    Open-Label Proof of Concept Pilot Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients with Alcohol Use Disorder.\n

  • IRAS ID

    198906

  • Contact name

    David Nutt

  • Contact email

    d.nutt@imperial.ac.uk

  • Sponsor organisation

    Imperial College London, Joint Research Compliance Office

  • Eudract number

    2016-002547-42

  • Clinicaltrials.gov Identifier

    16HH3426 , JRCO (Sponsor) reference

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    The physical, mental and societal problems associated with alcohol misuse are pervasive and on the increase, with almost 25% of adults in the UK now labelled as problem drinkers. After 100 years of modern psychiatry, outcomes for the successful treatment of alcohol use disorders remain poor. There are many different forms of traditional treatments available but all have high rates of relapse, making alcohol dependence one of the hardest diagnoses to treat in all of psychiatry. It is therefore an area of medicine that is well in need of an innovative approach. The drug MDMA has been used as a therapeutic agent to enhance psychotherapy for a wide range of mental disorders for almost 50 years - long before it became popular as the recreational drug Ecstasy. Despite the negative media bias that highlights the risks associated with recreational Ecstasy, clinical MDMA is entirely different. Delivered in a safe setting, after thorough screening of suitable patients, careful scrutiny of physiological measures and intensive integrative follow-up, a course of MDMA-Assisted Therapy can be an important opportunity for patients with alcohol dependence to maintain abstinence and recovery. This study aims to test whether when combined with careful, supervised psychotherapy in a controlled clinical setting by experienced therapists, MDMA could have the capacity to allow a patient to access, explore and resolve ingrained negative psychological dynamics that maintain addictive behaviours. Using an open-label design, with strict inclusion and exclusion criteria, we will examine whether 20 patients can use two sessions of MDMA-Assisted Therapy as part of a ten week course of non-drug psychotherapy sessions. The study will test the hypothesis that MDMA Therapy can be delivered safely and effectively in a clinical setting, offering patients a potential new approach to this devastating, chronic and relapsing condition. \n

  • REC name

    South West - Central Bristol Research Ethics Committee

  • REC reference

    16/SW/0273

  • Date of REC Opinion

    9 Dec 2016

  • REC opinion

    Further Information Favourable Opinion