Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02535494 |
| Other study ID # |
6723 |
| Secondary ID |
R01DA035207 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2014 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
February 2022 |
| Source |
New York State Psychiatric Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Design A significant cause of mortality among opioid users is overdose, which commonly
occurs following voluntary (opioid detoxification) or involuntary (incarceration) opioid
abstinence. For the purposes of the current application, opioid overdose is defined as use of
an opioid in an amount that results in over-sedation and/or respiratory depression requiring
intervention by medical or non-medical persons. Nearly 85% of overdoses occur in the presence
of a witness. Common methods of intervention by individuals without medical training are
ineffective techniques such as shaking the victim or injecting salt water. Naloxone is an
opioid antagonist that has long been used successfully by trained medical personnel during
emergency resuscitation following opioid overdose. In an effort to reduce fatal and non-fatal
opioid overdose, a number of states are implementing programs in which non-medical personnel
are provided brief instruction in recognizing the signs of opioid overdose and administering
naloxone. However, most of the existing programs are not designed to collect empirical data
on the safety and effectiveness of this intervention. Reporting of naloxone use is voluntary
and without incentive, and the experience of those who have been trained and prescribed
naloxone is not followed.
The proposed investigation will be 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. We 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, we 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. In addition to comparing outcome
variables in the TAU, ET and ETwSO groups prospectively, we will analyze data collected
before study initiation to compare fatal and non-fatal opioid overdose rates in neighborhoods
with facilities that offer overdose prevention training and naloxone to those that do not,
using data provided by our collaborators at the New York City (NYC) Department of Health and
Mental Hygiene (DOHMH).
Specific Aims and Hypotheses
- Primary Aim (Prospective Study): Determine the extent to which additional psychosocial
intervention can improve the effectiveness of current overdose prevention training as
measured by:
- increased frequency of naloxone use (ETwSO > ET > TAU)
- decreased number of opioid overdoses (ETwSO < ET < TAU)
- improved recognition of opioid overdose and naloxone indication knowledge (increased
BORRA scores; ETwSO > ET > TAU)
- Secondary Aim (Prospective Study): Determine the potential harms of this novel
naloxone-prescribing practice as measured by:
- proportion of participants calling 911 in response to an overdose, compared to
participants' recent history of calling 911 in response to an overdose
- risky drug use behavior (e.g. increased heroin/prescription opioid use, increased use of
illicit drug combinations) following training, compared to pre-training
Outcome Measures
Primary Outcome Measures (Prospective Study): Determine the extent to which additional
psychosocial intervention can improve upon the effectiveness of current overdose prevention
training by: 1) increasing the frequency of naloxone use among ET participants (continuous
variable); 2) decreasing the number of lethal opioid overdoses witnessed and experienced by
the ET group (continuous variable); 3) improving accurate recognition of opioid overdose and
naloxone indication knowledge (increased Brief Overdose Recognition and Response Assessment
(BORRA) score among ET participants (continuous variable). These variables will be assessed
repeatedly over the course of 1 year at: baseline (BL), immediately post-training (T0), 1-,
3-, 6- and 12-months (T1, T3, T6, and T12). The frequency of naloxone use and outcomes of the
overdose reversal attempts will be measured at T1, T3, T6, and T12 only.
Secondary Outcome Measures (Prospective Study): Evaluate the potential harms of this novel
naloxone-prescribing practice as assessed by: 1) decreased proportion of 911 calls in
response to an overdose, compared to participants' previous history of calling 911 while
witnessing an overdose (continuous variable); 2) changes in the use of illicit opioids, other
illegal drugs, or drug combinations following training (longitudinal continuous variable); 3)
prevalence of adverse events related to naloxone administration by non-medical personnel
(continuous variable).
