Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Acute and delayed effects of MDMA intoxication on false memories in a legal context

This trial (n=60) investigated the effect of MDMA (75mg) on the formation of memories. This was tested by simulating a crime (virtual reality). The trial found no significant effect of heightened vulnerability to external suggestions from MDMA.

Target Enrollment
80 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Background summary

False memories refer to memories of events/details that did not actually occur
(Otgaar, Howe, Brackmann, & Smeets, 2016). False memories frequently occur
spontaneously but can also be elicited through suggestive pressure. Legal cases have shown that eyewitnesses and innocent suspects can falsely remember to have seen non-existing details of a crime or falsely confess to have committed a
crime due to suggestive interrogation tactics of the police. Such false
memories can lead to wrongful convictions. Moreover, eyewitnesses and suspects
are often under influence of drugs such as MDMA while no knowledge base exists
whether their drugged state makes them more sensitive to spontaneous or
suggestion-based false memories. From a practical perspective, examining this
issue is highly relevant as MDMA is the second most widely used illicit drug in
the world, and is strongly prevalent in the Netherlands. In the courtroom,
eyewitness and suspect statements are seen as highly valuable evidence, thus
their reliability is important.

Study objective

Primary Objective: to assess the immediate and delayed effects of THC on true
and false memories in a legal context (i.e., on eyewitness and offender
statements).
Secondary Objective(s): to link drug-induced false memory effects to
dissociation
Tertiary objective: to assess functional connectivity in a subset of
participants in both treatment and control conditions in order to add to a
database of drug-induced changes in the brain, as well as link fMRI data to
false memory effects

Study design

The study will be conducted according to a double-blind, placebo-controlled, 2
(Group: Treatment vs. Control) by 2 (Time 1 vs. Time 2) crossover
mixed design with Group as a between-subjects factor. Occasional (N=64)
MDMA/ecstasy users will receive single doses of MDMA (75mg) and placebo according to a double-blind design in which they will be exposed to either an eyewitness scenario (Study 1a) or a perpetrator scenario (Study 1b). Each participant will be allocated to 1 of 2 groups (n=32 each) that receive eyewitness and perpetrator virtual reality scenarios during opposing treatment conditions. Groups will be matched according to sex, education and age. The major advantage of this approach is that participants will only be exposed once to each scenario (i.e. to exclude carryover and learning effects) while participating in both studies.

Intervention

i

Placebo (bitter lemon drink) and MDMA (75mg capsules dissolved in bitter lemon drink)

Study burden and risks

The participants will be administered placebo and MDMA in a crossover study.
They will view two different virtual reality mock crimes on separate testing
days, and subsequently their memory will be assessed. For more information see the research protocol.

Study Arms & Interventions

MDMA 75 mg

experimental

Interventions

  • MDMA75 mg
    via Oralsingle dose1 doses total

Placebo arm

inactive

Interventions

  • Placebo

Participants

Ages
1899
Sexes
Male & Female

Inclusion Criteria

  • Healthy volunteers who have experience with the use of ecstasy/MDMA (maximally 200 times in total, minimally 3 times in total; and at least once in the past 12 months): This will be assessed by means of a drug history questionnaire and an interview by the medical supervisor
  • Age between 18 and 40 years
  • Good physical health as determined by medical examination and laboratory analysis
  • Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
  • Written Informed Consent
  • Good knowledge and understanding of the English language (at least 5 years of English language education* assessed in the prescreening)

Exclusion Criteria

  • History of drug abuse (other than the use of MDMA) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
  • Pregnancy or lactation (pregnancy test, if needed)
  • Use of psychotropic medication (i.e. medication prescribed by a physician)
  • Any major medical, endocrine and neurological condition]
  • Decreased liver function
  • Hypertension (diastolic> 90; systolic> 140)
  • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
  • Liver dysfunction
  • (Serious) side effects due to previous MDMA consumption
  • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*)/ cardiovascular
  • abnormalities as indicated by (1) The medical questionnaire and/or (2) the standard 12-lead ECG
  • Previous participation in study NL60303.068.16, *Acute and delayed effects of THC intoxication on false memories in a legal context*

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2017-11-03
    End: 2020-12-30
  • Compounds
  • Topic

Study Team

Sponsors & Collaborators

  • Primary Sponsor

Locations

Maastricht UniversityMaastricht, Netherlands

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