MDMA Discontinuation Syndrome2CNCT01053403
Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.
A study of MDMA Discontinuation Syndrome, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how your body retains water. The researchers are interested in the effects that occur a few hours after taking MDMA as well as effects occurring over the next two days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- MDMA Discontinuation Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2011
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women aged 18 to 50 years.
- If female: abstains from heterosexual sex, not of childbearing potential, or reports using an approved contraceptive.
- Experienced with MDMA
- Fluent in English.
- Willing and able to give written consent.
- Healthy without medical contraindications to MDMA administration determined by the following: medical history, physical examination, 12-lead EKG, hematology, blood chemistry, and urinalysis.
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- Blood liver transaminase elevations up to 3 times the upper limit of normal.
- If female: negative pregnancy test at screening and at the beginning of each hospital admission.
- Negative urine drug test at screening and prior to each potential MDMA administration.
Who cannot join
- Current enrollment in a MDMA, alcohol, or other drug treatment program or current legal problems relating to MDMA, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer.
- Participants with a past-history of using only low doses of MDMA
- Currently trying to quit MDMA use.
- Current dependence on any other psychoactive drug (including nicotine).
- Significant physical or psychiatric illness that might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
- Likelihood of needing medications to treat an illness during the study period.
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- Body Mass Index > 30 or < 18.
- HIV seropositive by self-report.
- If female: pregnancy or lactation.
- History of serious adverse event or hypersensitivity to MDMA.
- Currently taking any medication other than over-the-counter non-steroidal anti-inflammatories, topical medications, inhaled asthma therapy, and over-the-counter non-sedating antihistamines.
- Male neck size ≥ 17 inches, female neck size ≥ 16 inches
- Modified Mallampati class ≥ 3.
- Recent travel within 3 days to or from a different time zone, other than Mountain Standard Time.
- Any other medical or psychosocial condition that would preclude useful, safe, or consistent participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, 94110
About this study
Official title: The Effects of MDMA on Sleep Architecture, Water Homeostasis and Cognitive Function
The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how your body retains water. The researchers are interested in the effects that occur a few hours after taking MDMA as well as effects occurring over the next two days. We will study these effects in a standardized, controlled setting at the Clinical and Translational Science Institute (CTSI) Clinical Research Center (CRC) located at San Francisco General Hospital.
The primary hypotheses are:
Read more
- MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist actigraphy, and self-report sleep measures
- MDMA will alter sodium and water homeostasis by either increasing or blunting the suppression of arginine vasopressin levels and decreasing free water excretion. Effects will be exacerbated by water loading.
Secondary hypotheses:
- Acutely, MDMA will increase both positive and negative arousal, and to increase sociability but not autonomy.
- Acutely, MDMA will increase risk-taking and willingness to donate money to others in an economic decision making task.
- MDMA will decrease the stressful effects of talking about a negatively-valenced autobiographical but will increase recall for details for these episodes.
- MDMA will increase oxidative stress markers and possible ameliorating factors (e.g., ADMA).
- The short form of the serotonin transported promoter region will be associated with greater acute and discontinuation effects of MDMA.
Read the detailed description
This is a placebo-controlled, double-blind, gender balanced, within-subject study on the acute and 24 to 48 hour post dose effects (discontinuation syndrome) of MDMA on sleep architecture, water homeostasis and neurocognitive function. We will define the signs and symptoms of sleep disruption and time course of alterations in ADH levels and neurocognitive function occurring after administration of a single dose of MDMA in experienced users. The immediate effects of MDMA include euphoria and intoxication; at 24 hours after MDMA these positive effects are replaced by lowered mood and lethargy - we refer to these effects as a discontinuation syndrome. The pleasurable effects of MDMA are thought to be due to elevations of serotonin, norepinephrine and dopamine; the mechanisms of post-MDMA depression are unknown but may be due to relative serotonin depletion. Among its many functions serotonin maintains normal sleep architecture. The effects of MDMA discontinuation on sleep architecture will be assessed using comprehensive polysomnography and wrist actigraphy with measures obtained ~36 hours after a single dose of MDMA. Cognitive measurements will explore the acute effects of MDMA. MDMA can produce hyponatremia. In this study we will evaluate the effects of MDMA on ADH release, urine sodium excretion, and the relationship of gender to these effects.
- Conditions
- MDMA Discontinuation Syndrome
- Being tested
- 3,4-methylenedioxymethamphetamine or Placebo
- Keywords
- MDMA, Ecstasy, MDMA effect on sleep, MDMA effect on water homeostasis, MDMA effect on neurocognitive function, Recreational Drug Use, Drug Abuse
- Medical subject headings
- Recreational Drug Use, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-methylenedioxymethamphetamine or PlaceboDrug
Also called Ecstasy
1.5mg/kg MDMA or matched Placebo administered during 2 inpatients stays. There are 2 dosing sessions and all subjects will receive MDMA at least one time.
| Study group | Role | What they receive |
|---|---|---|
| MDMA | Active comparator | Not described Receives: Drug: 3,4-methylenedioxymethamphetamine or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course, severity, and characteristics of MDMA discontinuation in experienced MDMA users given a known dose of MDMA
Measured: 1 hour post dose through 48 hours post dose
Relate observed discontinuation effects to sleep data: polysomnography, wrist actigraphy, and self-report sleep measures.
Measured: 1 hour post dose through 48 hours post dose
Assess the acute effects of MDMA on water and sodium homeostasis
Measured: 1 hour post dose through 48 hours post dose
Secondary outcomes (4)
Document the acute effects of MDMA on self-reported measures, including positive and negative arousal, autonomy, and sociability.
Measured: 1 hour post dose through 48 hours post dose
Document the acute effects of MDMA on behavioral measures of economic decision making.
Measured: 1 hour post dose through 48 hours post dose
Document the acute effects of MDMA on autobiographical speech and memory
Measured: 1 hour post dose through 48 hours post dose
Measure the effects of MDMA on ADMA
Measured: 1 hour post dose through 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDMA Discontinuation SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
- Investigators
- John Mendelson, MD, Principal investigator, CPMC Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053403
- Sponsor's protocol ID
- IRB# 2009.099-1 (JMen)
- Other IDs
- 5-R01-DA016776 (NIH), 5R01DA016776
- Acronym
- 2C
- Status last verified
- May 2013
- First submitted
- 8 Jan 2010
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of MDMA on Sleep Architecture, Water Homeostasis and Cognitive Function
- ClinicalTrials.gov ID
- NCT01053403
- Acronym / sponsor ID
- 2C / IRB# 2009.099-1 (JMen)
- Conditions
- MDMA Discontinuation Syndrome
- Keywords
- MDMA, Ecstasy, MDMA effect on sleep, MDMA effect on water homeostasis, MDMA effect on neurocognitive function, Recreational Drug Use, Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jan 2010 (estimated)
- 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.
The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how your body retains water. The researchers are interested in the effects that occur a few hours after taking MDMA as well as effects occurring over the next two days. We will study these effects in a standardized, controlled setting at the Clinical and Translational Science Institute (CTSI) Clinical Research Center (CRC) located at San Francisco General Hospital.
The primary hypotheses are:
- MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist actigraphy, and self-report sleep measures
- MDMA will alter sodium and water homeostasis by either increasing or blunting the suppression of arginine vasopressin levels and decreasing free water excretion. Effects will be exacerbated by water loading.
Secondary hypotheses:
- Acutely, MDMA will increase both positive and negative arousal, and to increase sociability but not autonomy.
- Acutely, MDMA will increase risk-taking and willingness to donate money to others in an economic decision making task.
- MDMA will decrease the stressful effects of talking about a negatively-valenced autobiographical but will increase recall for details for these episodes.
- MDMA will increase oxidative stress markers and possible ameliorating factors (e.g., ADMA).
- The short form of the serotonin transported promoter region will be associated with greater acute and discontinuation effects of MDMA.
Detailed description
This is a placebo-controlled, double-blind, gender balanced, within-subject study on the acute and 24 to 48 hour post dose effects (discontinuation syndrome) of MDMA on sleep architecture, water homeostasis and neurocognitive function. We will define the signs and symptoms of sleep disruption and time course of alterations in ADH levels and neurocognitive function occurring after administration of a single dose of MDMA in experienced users. The immediate effects of MDMA include euphoria and intoxication; at 24 hours after MDMA these positive effects are replaced by lowered mood and lethargy - we refer to these effects as a discontinuation syndrome. The pleasurable effects of MDMA are thought to be due to elevations of serotonin, norepinephrine and dopamine; the mechanisms of post-MDMA depression are unknown but may be due to relative serotonin depletion. Among its many functions serotonin maintains normal sleep architecture. The effects of MDMA discontinuation on sleep architecture will be assessed using comprehensive polysomnography and wrist actigraphy with measures obtained ~36 hours after a single dose of MDMA. Cognitive measurements will explore the acute effects of MDMA. MDMA can produce hyponatremia. In this study we will evaluate the effects of MDMA on ADH release, urine sodium excretion, and the relationship of gender to these effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA | Active comparator | Drug: 3,4-methylenedioxymethamphetamine or Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy men or women aged 18 to 50 years.
- If female: abstains from heterosexual sex, not of childbearing potential, or reports using an approved contraceptive.
- Experienced with MDMA
- Fluent in English.
- Willing and able to give written consent.
Key exclusion criteria (15 listed)
- Current enrollment in a MDMA, alcohol, or other drug treatment program or current legal problems relating to MDMA, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer.
- Participants with a past-history of using only low doses of MDMA
- Currently trying to quit MDMA use.
- Current dependence on any other psychoactive drug (including nicotine).
- Significant physical or psychiatric illness that might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
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-methylenedioxymethamphetamine or PlaceboAlso: Ecstasy1.5mg/kg MDMA or matched Placebo administered during 2 inpatients stays. There are 2 dosing sessions and all subjects will receive MDMA at least one time. | Drug | MDMA |
Primary outcome
Time course, severity, and characteristics of MDMA discontinuation in experienced MDMA users given a known dose of MDMA
Time frame: 1 hour post dose through 48 hours post dose
Relate observed discontinuation effects to sleep data: polysomnography, wrist actigraphy, and self-report sleep measures.
Time frame: 1 hour post dose through 48 hours post dose
Assess the acute effects of MDMA on water and sodium homeostasis
Time frame: 1 hour post dose through 48 hours post dose
4 secondary outcomes
Document the acute effects of MDMA on self-reported measures, including positive and negative arousal, autonomy, and sociability.
Time frame: 1 hour post dose through 48 hours post dose
Document the acute effects of MDMA on behavioral measures of economic decision making.
Time frame: 1 hour post dose through 48 hours post dose
Document the acute effects of MDMA on autobiographical speech and memory
Time frame: 1 hour post dose through 48 hours post dose
Measure the effects of MDMA on ADMA
Time frame: 1 hour post dose through 48 hours post dose
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 31 May 2013.
- Clinical Trials at the Addiction \& Pharmacology Research LaboratoryLink provided by the sponsor.
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.
John Mendelson, MD principal investigator
CPMC Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of MDMA Discontinuation Syndrome, run by California Pacific Medical Center Research Institute 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 9 inclusion and 15 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 31 May 2013. 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.
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?
Time course, severity, and characteristics of MDMA discontinuation in experienced MDMA users given a known dose of MDMA (time frame: 1 hour post dose through 48 hours post dose). The study lists 3 primary outcomes in all. 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 31 May 2013.