Oxytocin in response to MDMA provocation test in patients with arginine vasopressin deficiency (central diabetes insipidus): a single-centre, case-control study with nested, randomised, double-blind, placebo-controlled crossover trial
Primary result · Plasma oxytocin AUC after MDMAResult — go to the resultDifference 85 678 pg/mL 95% CI 63 356-108 000Authors' conclusion
These findings are highly suggestive of clinically meaningful oxytocin deficiency in patients with arginine vasopressin deficiency (central diabetes insipidus), laying the groundwork for a new hypothalamic-pituitary disease entity.
Study context
- Population
- Patients with AVP-D (central diabetes insipidus) and matched healthy controls, University Hospital Basel, Switzerlandall completed and analysed
- Participants
- 15 vs 15
- Comparison
- AVP-D patients vs healthy controls, MDMA 100 mg vs placebo
- Patientsn = 15
- Healthy controlsn = 15reference
- Primary endpoint
- AUC of plasma oxytocin concentration after drug intake
- Follow-up
- 0–300 min after MDMA or placebo
Methodological detailssingle-centre, double-blind, placebo-controlled, controls matched 1:1 by age, sex and BMI, Recruitment Feb 1, 2021 to May 1, 2022, Wash-out ≥2 weeks between sessions
- Single-centre
- Double-blind
- Placebo-controlled
- Controls matched 1:1 by age, sex and BMI
- Recruitment Feb 1, 2021 to May 1, 2022
- Wash-out ≥2 weeks between sessions
Primary result
Plasma oxytocin AUC after MDMA
Difference
85 678 pg/mL
95% CI 63 356-108 000
P < 0.0001
By group
As reported in the abstract
Further findings
| Outcome | Patients | Healthy controls |
|---|---|---|
| Baseline plasma oxytocin and increase with MDMAMedian, pg/mL | 60 (IQR 51–74) | 77 (IQR 59–94) |
| Increase with MDMA | 66 pg/mL (16-94) | 659 pg/mL (355-914) |
Subjective drug effects
- Strong subjective prosocial, empathic and anxiolytic effects in healthy controls; only minimal subjective effects in patients
Safety
| Outcome | Patients | Healthy controls |
|---|---|---|
| Adverse effects | ||
| Fatigue | 8 (53%) | 8 (53%) |
| Lack of appetite | 8 (53%) | 10 (67%) |
| Lack of concentration | 7 (47%) | 8 (53%) |
| Dry mouth | 8 (53%) | 8 (53%) |
| Transient mild hypokalaemia | 4 (27%) | 2 (13%) |
Original publication
Oxytocin in response to MDMA provocation test in patients with arginine vasopressin deficiency (central diabetes insipidus): a single-centre, case-control study with nested, randomised, double-blind, placebo-controlled crossover trial. Lancet Diabetes Endocrinol. Published 13 May 2023. doi:10.
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