HealthyPhase 1ESPNCT03790618
Effect of Stimulant Drugs on Social Perception
A Phase 1 study testing 3,4-Methylenedioxymethamphetamine and methamphetamine in people with Healthy and MDMA ('Ecstasy'), run by University of Chicago at 1 site in United States.
Trial summary
The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, MDMA ('Ecstasy')
- What is being tested?
- 3,4-Methylenedioxymethamphetamine and methamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- High school degree
- English fluency
- Healthy
- Has used MDMA
Who cannot join
- Pregnant or trying to become pregnant
- Any medical or psychiatry condition
Trial locations and contacts
1 site in 1 country.
About this study
The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.
- Conditions
- Healthy, MDMA ('Ecstasy')
- Being tested
- 3,4-Methylenedioxymethamphetamine, methamphetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-MethylenedioxymethamphetamineDrug
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
methamphetamineDrug
Please see above.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will attend one session during which they will receive a placebo capsule. Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: methamphetamine |
| Low dose MDMA | Experimental | Subjects will attend one session during which they will receive 0.75mg/kg MDMA. Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: methamphetamine |
| High dose MDMA | Experimental | Subjects will attend one session during which they will receive 1.5mg/kg MDMA. Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: methamphetamine |
| Methamphetamine | Experimental | Subjects will attend one session during which they will receive 20mg methamphetamine. Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: methamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to Affective Touch
Participants will complete an affective touch task during which time they will rate pleasantness of touch on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness
Measured: End of study (time 0 and approximately six weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jun 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790618
- Sponsor's protocol ID
- IRB15-780
- Acronym
- ESP
- Status last verified
- Mar 2023
- First submitted
- 30 Nov 2018
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bershad AK, Hsu DT, de Wit H. MDMA enhances positive affective responses to social feedback. J Psychopharmacol. 2024 Mar;38(3):297-304. doi: 10.1177/02698811231224153. Epub 2024 Jan 27.
PubMed 38279662
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stimulant Drugs on Social Perception
- ClinicalTrials.gov ID
- NCT03790618
- Acronym / sponsor ID
- ESP / IRB15-780
- Conditions
- Healthy, MDMA ('Ecstasy')
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 3,4-Methylenedioxymethamphetamine, Drug: methamphetamineSubjects will attend one session during which they will receive a placebo capsule. |
| Low dose MDMA | Experimental | Drug: 3,4-Methylenedioxymethamphetamine, Drug: methamphetamineSubjects will attend one session during which they will receive 0.75mg/kg MDMA. |
| High dose MDMA | Experimental | Drug: 3,4-Methylenedioxymethamphetamine, Drug: methamphetamineSubjects will attend one session during which they will receive 1.5mg/kg MDMA. |
| Methamphetamine | Experimental | Drug: 3,4-Methylenedioxymethamphetamine, Drug: methamphetamineSubjects will attend one session during which they will receive 20mg methamphetamine. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- High school degree
- English fluency
- Healthy
- Has used MDMA
Key exclusion criteria (2 listed)
- Pregnant or trying to become pregnant
- Any medical or psychiatry condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3,4-MethylenedioxymethamphetamineParticipants will be given 0.75mg/kg of 1.5mg/kg MDMA | Drug | High dose MDMA, Low dose MDMA, Methamphetamine, Placebo |
| methamphetaminePlease see above. | Drug | High dose MDMA, Low dose MDMA, Methamphetamine, Placebo |
Primary outcome
Responses to Affective Touch
Time frame: End of study (time 0 and approximately six weeks later)
Participants will complete an affective touch task during which time they will rate pleasantness of touch on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38279662Bershad AK, Hsu DT, de Wit H. MDMA enhances positive affective responses to social feedback. J Psychopharmacol. 2024 Mar;38(3):297-304. doi: 10.1177/02698811231224153. Epub 2024 Jan 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3,4-Methylenedioxymethamphetamine and methamphetamine in people with Healthy and MDMA ('Ecstasy'), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responses to Affective Touch (time frame: End of study (time 0 and approximately six weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.