Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients (NCT02093559) | Clinical Trial Compass
CompletedNot Applicable
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
United States63 participantsStarted 2014-07
Plain-language summary
REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 18-65 years;
* current opioid dependence by SCID
* urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
* history of prior opioid overdose
* previously received take-home naloxone
* no serious illnesses likely to progress clinically during trial
* able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule
Exclusion Criteria:
* suicidal ideation by concise health risk tracking (CHRT)
* currently participating in another interventional research study that could possible impact the study's outcomes of interest
* any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of a randomized trial with REBOOT
Timeframe: 16 months
2
Acceptability of REBOOT
Timeframe: 16 months
3
Influence of egocentric social network characteristics on overdose events and naloxone use