Smartphones for Opiate Addiction Recovery
ConditionOpioid-use Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Factorial
Treatments tested in this trial
Smartphone app
Other interventionSOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.
Treatment groups
225 Participants
are divided into 5 treatment groupsGroup A: Treatment-as-UsualNo intervention 0 interventions
Group B: Smartphone with dose changes after usingExperimental treatment 1 intervention
Group C: Smartphone with dose changes before usingExperimental treatment 1 intervention
Group D: Focus group with Study PhysicansExperimental treatment 1 intervention
Group E: Focus group with CliniciansExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
This is measured by collecting one salivary drug test every two weeks in addition to any drug testing they may complete as part of their clinical treatment. Once saliva samples are obtained they will be aggregated and sent weekly for analysis by mass spectrometry. The primary outcome from these data will be the number of toxicology tests positive for illicit opioids. These data are count in nature and truncated at both 0 and 12.
Time frame
1 month visit, 3 months visit, 6 months visitSecondary outcomes
1
To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU
This will be measured through self reports through the smartphone and assessed by randomly scheduled, remote drug screens with saliva samples.
Time frame
1 month visit, 3 months visit, 6 months visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov