MDMA & Alcohol Use Disorder

Today, we’re reviewing a proof-of-concept study conducted by researchers at Imperial College London. The Bristol Imperial MDMA in Alcoholism (BIMA) study is the first study investigating whether there is a potential role for MDMA in treating alcohol use disorder (AUD).

 

What is a Safety and Tolerability Study?

Today’s study is an open-label, proof-of-concept safety and tolerability study.

What does that mean?

“Open-label” means that both participants in the study, as well as the researchers, knew what treatment the participants received. So, study participants knew they were receiving MDMA, and the researchers knew participants received MDMA. This is different from a blinded study, where participants (and sometimes, the researchers as well) aren’t told which treatment they receive. The goal with “blinding” a study is to help control for the placebo effect.

A proof-of-concept safety and tolerability study tells us that the study is very small – for this specific study, only 14 participants were recruited. The goal is to test the drug in a small group of people to evaluate the drug’s safety. Can the drug be delivered safely? Is it relatively safe, or does it cause severe or intolerable side effects? And, how does the dose affect these results?

Researchers typically enter these sorts of studies with some general ideas or thoughts regarding drug dosing and expected effects – but these theories still need to be evaluated in a study setting. However, we don’t want to conduct large-scale studies until we have a better understanding of what doses are safe and what effects can be expected.

 

Study Details

We’re gonna cover study details in a quick-hitting paragraph:

14 patients were enrolled; prior to the study, each had completed a community-based alcohol detoxification. Each participant also received recovery-based therapy for eight weeks.

Exclusion criteria were used to screen and identify people who should not participate in the study. In other words, people were not allowed to participate if any of the following applied (note: this list is not exhaustive, see the full study for full details)

• Current or history of a primary psychotic disorder

• Serious risk for suicide, as determined using the Columbia-Suicide Severity Risk Scale (C-SSRS)

• Current or history of heart disease, including high blood pressure

• History of stroke

• Severe liver disease

• Regular ecstasy use – such as five or more times in the past five years, or two or more times in the six months prior to the study

• Regular use of cannabis, cocaine, or heroin

Each participant underwent two MDMA sessions. The dose used for each session was 187.5 milligrams (mg). Participants received psychological support during the session, as well as before and after.

Researchers evaluated outcomes around:

• Drinking habits and behaviors

• Psychosocial functioning

• Quality of life

 

What Did This Study Find?

Of the 14 participants, 12 received both MDMA-assisted psychotherapy sessions.

Prior to detox and the MDMA-assisted psychotherapy sessions, participants consumed an average of 130.6 units of alcohol per week. One unit of alcohol equals 10 milliliters (mL). A pint of 4% ABV beer contains about 2.3 units. One bottle (750 mL) of wine contains 9.8 units.

So, what was the average weekly alcohol consumption after the study? At nine months following detox and MDMA-assisted psychotherapy, participants consumed an average of 18.7 units of alcohol per week – a nearly 86% decrease.

No unexpected side effects were reported. Researchers used a survey called Subjective Units of Distress (SUDS) to measure side effects experienced during the sessions. Most participants reported increased SUDS scores prior to the session – understandable, given the anxiety that is expected prior to MDMA dosing. SUDS scores subsequently dropped during sessions after participants received their MDMA dose.

No participants needed medical attention. No participants reported any significant impairment to cognitive function in the weeks and months following study participation.

 

What’s Next?

This proof-of-concept study provides a launching point to evaluate MDMA-assisted psychotherapy for treating alcohol-use disorder in a larger population, including Phase-II equivalent dose-finding studies. Proof-of-concept studies often serve as a “go or no” turning point – if they fail, the drug may be abandoned for treating the condition in question; if the study is a success, researchers often elect to go “full speed ahead” into the next steps. Strike while the iron is hot!

This study could also lead to similar studies evaluating MDMA-assisted psychotherapy for treating other substance use disorders, such as opioid use disorder. This study can be used as a blueprint which may speed up the process for researchers interested in exploring MDMA for OUD or other substance use disorders.

When (not if) those studies happen, we’ll go over them together here!

 

 

Reference: 

Sessa B, Higbed L, O’Brien S, et al. First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Journal of Psychopharmacology. 2021;35(4):375-383. doi:10.1177/0269881121991792