NCT05033028 Smartphones for Opiate Addiction Recovery
| NCT ID | NCT05033028 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | NYU Langone Health |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 225 participants in total. It began in 2021-11-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.
Eligibility Criteria
Inclusion Criteria: Patients: * Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids); * Have entered, or expressed a clear intention to enter, an OUD treatment program that prescribes either methadone or buprenorphine * Any gender; * 18 years of age and older; * Have used opioids other than as specifically prescribed within thirty days prior to consent; * In good-enough general health; * Capacity to provide written informed consent as assessed by our Subject Comprehension Assessment Tool(subjects lacking the ability to consent will not be enrolled) ; * Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study. Study-Physician Participants. * Licensed MD employed by the respective site, or at a clinical partner of the respective site, where they will act as participants and be part of the treatment team * Currently practicing in the treatment of OUD with either Buprenorphine or Methadone; * Able to speak, read, and write English fluently and to provide informed consent in English Clinician Participants. * Licensed MSW, NP, or MD; who are not part of any treatment team within the study and may be employees of their respective sites or other treatment facilities. * Currently practicing in the treatment of OUD with either Buprenorphine or Methadone; * Able to speak, read, and write English fluently and to provide informed consent in English Exclusion Criteria: Patients: * Serious medical, psychiatric or non-opioid substance use disorder that, in the opinion of a study physician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study. Examples include: (a) Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments; * Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview; * Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included); * Suicidal or homicidal ideation that requires immediate attention; * Presence of pain of sufficient severity as to require ongoing pain management with opioids; * Pending legal action or other reasons that might prevent an individual from completing the study. * Pregnancy as assessed by urine pregnancy testing * Breastfeeding of infants, as assessed by self-report. * Prisoners, as defined by OHRP, are excluded from participation in the study. * Individuals receiving residential court-ordered substance abuse treatment. Study-Physician Participants. * none Clinician Participants. * none
Contact & Investigator
Stephen Ross, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05033028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05033028 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 225 participants.
Is NCT05033028 currently recruiting?
Yes, NCT05033028 is actively recruiting participants. Contact the research team at Paul.glimcher@nyulangone.org for enrollment information.
Where is the NCT05033028 trial being conducted?
This trial is being conducted at Piscataway, United States, New York, United States.
Who is sponsoring the NCT05033028 clinical trial?
NCT05033028 is sponsored by NYU Langone Health. The principal investigator is Stephen Ross, MD at NYU Langone Health. The trial plans to enroll 225 participants.