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NCT02535494 · ClinicalTrials.gov registry record · NA
Risks and Benefits of Naloxone Prescribing
A NA study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- NA
- Development phase
- 405
- Enrollment target
NCT02535494 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 405 participants.
The verdict
NCT02535494, a NA study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 405 participants
- Enrollment target
Study Summary
This investigation is one of the first large-scale, prospective attempts to obtain data on the effectiveness of naloxone distribution among opioid-abusing populations at high risk of unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug detoxification sites as well as those accessing services at needle exchange programs. All participants (N=700) will receive the standard opioid overdose education and naloxone. One third of the participants will be randomized to receive additional in-depth psychosocial education focusing on recognition and prevention of opioid overdose, and appropriate use of naloxone. Another third of the participants will receive the extensive training and be required to engage a spouse, partner, relative, or friend in this supplementary intervention. The investigators plan to randomize individuals to each group \[Treatment as Usual (TAU) vs. Extensively Trained (ET) vs. Extensively Trained with a Significant Other (ETwSO)\] and, through continued follow up over one year, the investigators will compare self-reported overdose reversal attempts (with and without naloxone use), naloxone-related adverse events, and changes in patterns of heroin and other drug use.
Interventions
- OTHER Extensive training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02535494
The ClinicalTrials.gov registry entry for NCT02535494 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 405 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 1 intervention - of which Extensive training is the first listed.
NCT02535494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02535494 about?
NCT02535494 is a clinical study titled "Risks and Benefits of Naloxone Prescribing". This investigation is one of the first large-scale, prospective attempts to obtain data on the effectiveness of naloxone distribution among opioid-abusing populations at high risk of unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug detoxification sites as well...
What is the current status of trial NCT02535494?
This trial is currently completed. It is a NA study. The enrollment target is 405 participants. The study started on 2014-07. Estimated completion is 2021-12.
What interventions are being tested in trial NCT02535494?
The interventions under investigation include: Extensive training (OTHER).
Who is sponsoring clinical trial NCT02535494?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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