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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
no health condition is addressed in the research, and healthy volunteers who are occasional MDMA users will be recruited
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Spontaneous false memories will be measured using the
Deese/Roediger-McDermott (DRM) paradigm. Suggestion-based
false memories will be assessed via exposing subjects to a virtual reality mock
crime and adding suggestive misinformation in subsequent interrogations.
Secondary outcome
Secondary: Dissociative psychopathology (i.e., dissociative traits) will be
measured using the Dissociative Experiences Scale (DES). Reality
monitoring/dissociative symptoms (i.e., dissociative states) will be assessed
using the Clinician Administered Dissociative States Scale (CADSS). Other
parameters include constructs related to (false) memory, such as attention,
information processing, compliance, arousal, and convergent and divergent
thinking.
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
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.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
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*
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2016-004982-22-NL |
CCMO | NL62794.068.17 |
OMON | NL-OMON25089 |