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NCT02255357 · ClinicalTrials.gov registry record · Phase 2
Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02255357 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 43 participants.
The verdict
NCT02255357, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.
Interventions
- DRUG Placebo
- DRUG Intranasal Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-02-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02255357
The ClinicalTrials.gov registry entry for NCT02255357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02255357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02255357 about?
NCT02255357 is a clinical study titled "Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.". This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, ...
What is the current status of trial NCT02255357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-03. Estimated completion is 2018-02-14.
What interventions are being tested in trial NCT02255357?
The interventions under investigation include: Placebo (DRUG), Intranasal Oxytocin (DRUG).
Who is sponsoring clinical trial NCT02255357?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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