No registrations found.
ID
Source
Brief title
Health condition
Participants are healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
Spontaneous and suggestion-based false memories will be assessed by using established false memory paradigms (associatively-related word lists, mock crime).
Secondary outcome
Dissociative states and traits will be assessed using both established self-report and clinician-administered measures. Functional connectivity will be assessed using resting state fMRI.
Background summary
Rationale: 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. Eyewitnesses and suspects are often under the influence of the party-drug ecstasy (MDMA) but little knowledge exists whether their drugged state makes them more vulnerable to spontaneous or suggestion-induced false memories.
Objective: Objectives of this study are twofold. The current project will examine the impact of MDMA intoxication on susceptibility to false memories and dissociation. Additionally, the effect of MDMA on functional connectivity between the striatum and the prefrontal cortex will be studied using fMRI in a subset of participants.
Study design: Acute and delayed influences of MDMA on false memory formation will be assessed in a placebo-controlled study in occasional MDMA users, using a virtual reality (VR) eyewitness and a perpetrator scenario. The order of treatments and scenarios will be counterbalanced across participants.
Study population: Sixty-four healthy, occasional MDMA users, aged 18-40.
Intervention (if applicable): Placebo and MDMA (75mg)
Main study parameters/endpoints: Spontaneous and suggestion-based false memories will be assessed by using established false memory paradigms (associatively-related word lists, mock crime). Dissociative states and traits will be assessed using both established self-report and clinician-administered measures. Functional connectivity will be assessed using resting state fMRI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will visit our lab five times. The first visit includes a full medical screening by a licensed physician ensuring their safety, which will include a medical history review, a blood sample (12 ml), and an electrocardiogram recording. The second includes a short training session to familiarize them with the testing procedures and (potentially) the MRI scanner. During the third and fourth visit, participants will be administered placebo and MDMA (capsule) and be exposed to two distinct mock crime Virtual Reality (VR) scenarios on two separate occasions, each followed by an immediate and a one-week follow-up assessment, including measures of true and false memory and dissociative states and traits. Moreover, a subset of 12 participants will undergo a resting state functional connectivity assessment inside the magnetic resonance scanner (time in MRI scanner is ~20 minutes). Finally, participants will return a week later for a brief follow up visit (20 minutes) in which they will receive follow-up false memory tests.
Study objective
It is expected that participants in the MDMA condition will be more susceptible to false memory formation, and that this will be mediated by dissociation.
Study design
week 0: medical screening
week 1: training
week 2: testing session 1
week 3: testing session 2
week 4: followup
Intervention
75mg dose of 3,4-methylenedioxymethamphetamine (MDMA) vs placebo
Inclusion criteria
• Experience with the use of MDMA/ecstasy (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, such as antidepressants or antipsychotics, not including contraceptives or painkillers such as ibuprofen)
• 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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7423 |
| NTR-old | NTR7665 |
| CCMO | NL62794.068.17 |
| OMON | NL-OMON44349 |