New treatment option for Opioid-use Disorder
Official title Smartphones for Opiate Addiction Recovery
ClinicalTrials.gov ID: NCT05033028
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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;
You likely can't join if
- Patients:
- Serious medical, psychiatric or non-opioid substance use disorder that, in the opinion of a study physician, would make study participation hazardous...
- Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history...
- Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine...
- Suicidal or homicidal ideation that requires immediate attention;
- Presence of pain of sufficient severity as to require ongoing pain management with opioids;
See the full eligibility 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(people 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Piscataway, New Jersey, United States
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Piscataway, New Jersey, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.