Mobile Intervention for Young Opioid Users
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|ClinicalTrials.gov Identifier: NCT03610672|
Recruitment Status : Unknown
Verified July 2018 by National Development and Research Institutes, Inc..
Recruitment status was: Recruiting
First Posted : August 1, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Behavioral: OD prevention/response training Behavioral: OD prevention/response training + PI mobile application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||The current study is a two-armed, open randomized clinical trial design.|
|Masking:||None (Open Label)|
|Official Title:||Preventing Injection: An mHealth Intervention That Leverages Social Networks to Prevent Progression to Injection Among Young Opioid Users|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||November 28, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Active Comparator: OD prevention/response training
Immediately following the baseline assessment, trained research staff will conduct a brief (20 min.) OD training with each participant. Participants will be asked to view the NYC Department of Health and Mental Hygiene's 13-minute OD prevention and response training video (available online free-of-charge). Following the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to execute this assembly procedure. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.
Behavioral: OD prevention/response training
Participants will view a 13-minute OD prevention and response training video (available online free-of-charge). This video covers NY State's recommended curriculum for Overdose Prevention: how to prevent, identify, and respond to an OD, including information on the factors that could heighten risk for overdose (mixing drugs, changes in tolerance and drug purity, and using alone), how to respond to an overdose (rescue breathing, calling 911), and specific instructions on how and when to administer naloxone to someone who is overdosing. After the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to assemble it. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.
Experimental: OD training + mobile PI intervention
Participants will complete the same baseline assessment and OD training (plus naloxone) as those in the first condition. Participants also will receive mobile phones pre-loaded with the PI App and will be sent daily prompts. As part of the PI App, participants will be asked to share information about avoiding problems associated with opioid use with peers in their social network, and to encourage their peers to download the PI App for their own use.
Behavioral: OD prevention/response training + PI mobile application
Participants will receive the same OD intervention as those in the first arm, as well as receiving mobile phones pre-loaded with the PI App. This intervention includes daily prompts plus key components of evidence-based cognitive behavioral interventions, including Functional Analysis of Drug Use, Self-Management, and Social/Recreational Counseling and additional content on Distress Tolerance, the relationship between Peer Networks and Drug Use, and pertinent resources.
- Change in opioid use [ Time Frame: Change from baseline to 12 weeks ]Participant opioid use will be assessed via self-reported Timeline Followback, urine toxicology, and hair toxicology
- Change in self-reported injection status via Timeline Followback [ Time Frame: Change from baseline to 12 weeks ]Self-reports of frequency and duration of injection drug use
- Change in HIV/HCV risk behavior [ Time Frame: Change from baseline to 12 weeks ]self-reported HIV/HCV risk behavior (combined injection and sexual risk behavior)
- OD [ Time Frame: 12 weeks ]frequency and severity of self-reported overdose (OD) episodes
- Peer IDU norms [ Time Frame: Change from baseline to 12 weeks ]Self-reported perceptions of peer injection drug use-related norms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610672
|Contact: Michelle Acostafirstname.lastname@example.org|
|Contact: Honoria Guarinoemail@example.com|
|United States, New York|
|National Development and Research Institutes, Inc.||Recruiting|
|New York, New York, United States, 10010|
|Contact: Lisa Bernhard 212-845-4567 firstname.lastname@example.org|
|Principal Investigator:||Michelle Acosta||NIDA/NIH|