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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: Completed NA study, sponsored by New York State Psychiatric Institute.

NCT02535494 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 405 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Determine the extent to which additional psychosocial intervention can improve upon the effectiveness of current overdose prevention training by increasing the frequency of naloxone use

Interventions

  • OTHER Extensive training

Trial Details

FieldValue
Enrollment Target 405 participants
Start Date 2014-07
Est. Completion 2021-12
Phase NA

What the finished NCT02535494 record still lists

NCT02535494 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 1 intervention - of which Extensive training is the first listed.

NCT02535494 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02535494's enrollment target sits among peer trials

405 243rd of 2000 higher than 1,757 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02535494, the US trial registry maintained by the National Library of Medicine. NCT02535494 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.