Stimulant UseEarly Phase 1MASMNCT05379959
Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
A Early Phase 1 study testing MDMA and Methamphetamine in people with Stimulant Use and MDMA ('Ecstasy'), run by University of Chicago at 1 site in United States.
Trial summary
To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stimulant Use, MDMA ('Ecstasy'), Social Behavior
- What is being tested?
- MDMA and Methamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 24 Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 19 and 30 (no one under 130 lbs)
- Smokers smoking less than 25 cigarettes per week
- Have used ecstasy no more than 40 times with no adverse responses.
Who cannot join
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Individuals with a history of dependence on stimulant drugs.
- Women who are pregnant or trying to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers
- Conditions
- Stimulant Use, MDMA ('Ecstasy'), Social Behavior, Motivation
- Being tested
- MDMA, Methamphetamine, placebo oral tablet
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Participants will be given 125 mg of MDMA.
MethamphetamineDrug
Participants will be given 20 mg of MA.
placebo oral tabletDrug
Participants will be given a placebo capsule that will only contain lactose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Placebo Then MDMA Then Methamphetamine | Experimental | Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA. Receives: Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet |
| Experimental: MDMA Then Placebo Then Methampetamine | Experimental | Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA. Receives: Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet |
| Experimental: Methampetamine Then Placebo Then MDMA | Experimental | Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA. Receives: Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Measured: Time Frame: Baseline-72 hours after completion of the sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start11 May 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant UseStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 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
- NCT05379959
- Sponsor's protocol ID
- IRB21-1568
- Acronym
- MASM
- Status last verified
- Jan 2024
- First submitted
- 13 May 2022
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
- ClinicalTrials.gov ID
- NCT05379959
- Acronym / sponsor ID
- MASM / IRB21-1568
- Conditions
- Stimulant Use, MDMA ('Ecstasy'), Social Behavior, Motivation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Placebo Then MDMA Then Methamphetamine | Experimental | Drug: MDMA, Drug: Methamphetamine, Drug: placebo oral tabletParticipants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA. |
| Experimental: MDMA Then Placebo Then Methampetamine | Experimental | Drug: MDMA, Drug: Methamphetamine, Drug: placebo oral tabletParticipants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA. |
| Experimental: Methampetamine Then Placebo Then MDMA | Experimental | Drug: MDMA, Drug: Methamphetamine, Drug: placebo oral tabletParticipants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 19 and 30 (no one under 130 lbs)
- Smokers smoking less than 25 cigarettes per week
- Have used ecstasy no more than 40 times with no adverse responses.
Key exclusion criteria (5 listed)
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Individuals with a history of dependence on stimulant drugs.
- Women who are pregnant or trying to become pregnant
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 |
|---|---|---|
| MDMAParticipants will be given 125 mg of MDMA. | Drug | Experimental: MDMA Then Placebo Then Methampetamine, Experimental: Methampetamine Then Placebo Then MDMA, Experimental: Placebo Then MDMA Then Methamphetamine |
| MethamphetamineParticipants will be given 20 mg of MA. | Drug | Experimental: MDMA Then Placebo Then Methampetamine, Experimental: Methampetamine Then Placebo Then MDMA, Experimental: Placebo Then MDMA Then Methamphetamine |
| placebo oral tabletParticipants will be given a placebo capsule that will only contain lactose. | Drug | Experimental: MDMA Then Placebo Then Methampetamine, Experimental: Methampetamine Then Placebo Then MDMA, Experimental: Placebo Then MDMA Then Methamphetamine |
Primary outcome
Profile of Mood States
Time frame: Time Frame: Baseline-72 hours after completion of the sessions
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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 Early Phase 1 study testing MDMA and Methamphetamine in people with Stimulant Use 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 3 inclusion and 5 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 24 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Profile of Mood States (time frame: Time Frame: Baseline-72 hours after completion of the sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.