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Prevention Strategies for Opioid Use Disorder
N/A
Waitlist Available
Led By Jennifer McNeely, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Risky opioid use in the past 90 days from date of prescreening, as determined by a TAPS score >1 for heroin and/or prescription opioids and/or a positive response (>Never) to any of the three COMM items indicating taking more opioid medication than prescribed.
Age 18 years or older at time of prescreening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 3, 6, 9 and 12 months
Awards & highlights
Study Summary
This trial will test if a new intervention can help reduce opioid use and prevent progression to addiction in adults who use opioids.
Who is the study for?
The STOP trial is for adults with unhealthy opioid use who are at risk of developing Opioid Use Disorder (OUD). Participants must be patients of a licensed medical professional enrolled in the study, have risky opioid use, and access to phone and internet. They should not have moderate-severe OUD, recent MOUD treatment, or other conditions that could interfere with the study.Check my eligibility
What is being tested?
This trial tests a primary care intervention called STOP versus enhanced usual care to prevent progression to OUD. It involves PCP brief advice, video doctor consultations, telephone health coaching, and Nurse Care Manager interventions in a cluster-randomized design across five sites.See study design
What are the potential side effects?
As this is a behavioral intervention involving advice and coaching rather than medication or invasive procedures, significant physical side effects are not expected. However, participants may experience stress or emotional discomfort related to discussions about their opioid use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have used opioids riskily in the last 3 months.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at 3, 6, 9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 3, 6, 9 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the number of days of Opioid use
Secondary outcome measures
Acute health care utilization
Change in Mental health
Change in Overdose risk behaviors and events
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Subthreshold Opioid Use Disorder Prevention(STOP) InterventionExperimental Treatment4 Interventions
At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
PCPs will conduct primary care as usual, without the support of the NCM. At the baseline visit, patient participants receive an educational pamphlet and view a short video on overdose and cancer screening. The pamphlet includes information about preventing opioid-related overdose, including how to obtain a naloxone kit. The video content will feature the health benefits of exercise. It will be viewed on a tablet or desktop computer and will be approximately 2 minutes long. All EUC patient participants receive the same video, which is not tailored to the responses given on their questionnaires. There is no study intervention after the baseline visit.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,529 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,396 Total Patients Enrolled
Jennifer McNeely, MDPrincipal InvestigatorNYU Langone
2 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not plan to move away from the area where the trial is conducted within a year.I am taking opioids for end-of-life care.I am willing to be assigned to any of the study groups.I am not pregnant.I plan to change my work schedule in the next 2 years, affecting my patient volume.I have used opioids riskily in the last 3 months.I am willing to be assigned to any treatment group in the study.Nothing will stop me from fully participating in the study.I am 18 years old or older.I see 40 or more adult patients weekly.I currently care for 4 or more adults on chronic opioid treatment or with risky opioid use.I see 40 or more adult patients weekly.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care (EUC)
- Group 2: Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this research project for individuals to enroll?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was initially published on March 25th 2020, is still recruiting participants. Approximately 300 individuals must be recruited from one site to complete the research study."
Answered by AI
What is the numerical limit of participants in this clinical trial?
"Affirmative. Clinical trial data on clinicaltrials.gov verifies that this study is currently enrolling participants, with the initial post made on March 25th 2020 and last updated October 9th 2022. The requirement is 300 individuals from a single site."
Answered by AI
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