Trial Outcomes & Findings for Increasing Naloxone Access for Persons Who Use Opioids (NCT NCT04303000)
NCT ID: NCT04303000
Last Updated: 2023-10-30
Results Overview
Feasibility of online opioid overdose education and remote naloxone distribution as indicated by recruitment of at least 80 total participants in 6 months. There was not a calculated measure, and this aspect of feasibility was based on ability to recruit a set number of participants in a predetermined amount of time.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
111 participants
Primary outcome timeframe
6 months
Results posted on
2023-10-30
Participant Flow
Participants were recruited via online social media platforms (e.g., Craigslist) between July and October 2021.
A total of 13 participants were not randomized to a group for the training portion of the study, as they did not complete the baseline assessment.
Participant milestones
| Measure |
Screened Participants
Started and completed screening
|
Opioid Overdose Education and Naloxone Distribution
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm were provided with a naloxone nasal spray kit (4mg).
Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
|
Opioid Overdose Education
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm received information about pharmacies in their area where they could purchase a naloxone kit.
Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
|
|---|---|---|---|
|
Opioid Use Questionnaire
STARTED
|
319
|
0
|
0
|
|
Opioid Use Questionnaire
COMPLETED
|
304
|
0
|
0
|
|
Opioid Use Questionnaire
NOT COMPLETED
|
15
|
0
|
0
|
|
Training Portion
STARTED
|
0
|
55
|
56
|
|
Training Portion
Month 1 Follow-Up
|
0
|
48
|
50
|
|
Training Portion
Month 2 Follow-Up
|
0
|
48
|
50
|
|
Training Portion
Month 3 Follow-Up
|
0
|
47
|
48
|
|
Training Portion
COMPLETED
|
0
|
45
|
47
|
|
Training Portion
NOT COMPLETED
|
0
|
10
|
9
|
Reasons for withdrawal
| Measure |
Screened Participants
Started and completed screening
|
Opioid Overdose Education and Naloxone Distribution
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm were provided with a naloxone nasal spray kit (4mg).
Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
|
Opioid Overdose Education
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm received information about pharmacies in their area where they could purchase a naloxone kit.
Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
|
|---|---|---|---|
|
Opioid Use Questionnaire
Withdrawal by Subject
|
15
|
0
|
0
|
Baseline Characteristics
Increasing Naloxone Access for Persons Who Use Opioids
Baseline characteristics by cohort
| Measure |
Opioid Overdose Education and Naloxone Distribution
n=55 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm were provided with a naloxone nasal spray kit (4mg).
Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
|
Opioid Overdose Education
n=56 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm received information about pharmacies in their area where they could purchase a naloxone kit.
Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.44 years
STANDARD_DEVIATION 9.08 • n=93 Participants
|
38.54 years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
37.93 years
STANDARD_DEVIATION 9.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsFeasibility of online opioid overdose education and remote naloxone distribution as indicated by recruitment of at least 80 total participants in 6 months. There was not a calculated measure, and this aspect of feasibility was based on ability to recruit a set number of participants in a predetermined amount of time.
Outcome measures
| Measure |
Opioid Overdose Education and Naloxone Distribution
n=55 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm were provided with a naloxone nasal spray kit (4mg).
Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
|
Opioid Overdose Education
n=56 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm received information about pharmacies in their area where they could purchase a naloxone kit.
Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
|
|---|---|---|
|
The Number of Participants That Completed the Training in 6 Months
Enrolled and Randomized
|
55 Participants
|
56 Participants
|
|
The Number of Participants That Completed the Training in 6 Months
Lost to Follow-up
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMean change in participant knowledge as indicated by difference in scores on pre- and post-training knowledge questionnaires on a scale of 1 to 9 where 9 indicates greater knowledge.
Outcome measures
| Measure |
Opioid Overdose Education and Naloxone Distribution
n=55 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm were provided with a naloxone nasal spray kit (4mg).
Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
|
Opioid Overdose Education
n=56 Participants
Participants engaged in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm received information about pharmacies in their area where they could purchase a naloxone kit.
Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
|
|---|---|---|
|
Change in Participant Knowledge of Opioid Overdose Response Procedures
|
1.48 score on a scale
Standard Deviation 1.83
|
1.34 score on a scale
Standard Deviation 1.51
|
Adverse Events
Opioid Overdose Education and Naloxone Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid Overdose Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place