Risks and Benefits of Naloxone Prescribing
Public ClinicalTrials.gov record NCT02535494. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Risks and Benefits of Overdose Education and Naloxone Prescribing to Heroin Users
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02535494
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 405 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2014
- Primary completion
- Apr 30, 2021
- Completion
- Nov 30, 2021
- Last update posted
- Mar 1, 2022
2014 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02535494, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2022 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02535494 live on ClinicalTrials.gov.