Yes. However, the patient will not be re-enrolled and will not be re-randomized. We will continue follow-up with the patient based on their initial enrollment date. Whatever induction method and treatment is used after the patient’s initial randomization will be done at the clinician’s discretion. We will record that information as part of follow-up, but the initial assigned arm will remain the same for the purpose of our analysis.
Please note that patient eligibility criteria for initial enrollment in HOMER include that the patient be identified by their clinician as having opioid dependence and either 1) addiction as defined by DSM-V criteria for OUD and/or 2) chronic pain with long-term, high dose opioid use (greater than one year and morphine equivalent daily dose higher than recommended by the CDC). However, if a patient enrolls and starts treatment, stops treatment, then starts up again, there is no required amount of time between stopping and re-starting treatment. Again, we will document that.