The induction phase is completed and the stabilization phase (usual duration approximately 1 to 2 months) is begun when the patient is experiencing no withdrawal symptoms, is experiencing minimal or no side effects, and no longer has uncontrollable cravings for opioid agonists. (SAMHSA, p. 56).
When a patient has achieved medical stabilization, his or her goals will vary significantly. At the one extreme will be patients who are highly motivated to engage in 12-step programming, commit to full abstinence from all non-prescribed substances, and who gradually make recovery from addiction a significant aspect of their personal identity. At the other extreme will be patients who stabilize on buprenorphine and have largely eliminated illicit opioid use but have modest recovery goals. These patients may continue to use substances regularly. If their lives are substantially improved and their risk for death decreased with the help of buprenorphine therapy, buprenorphine treatment will continue to be indicated. These patients are not unlike patients with hypertension and hypercholesterolemia who benefit from pharmacotherapy but make minimal additional lifestyle changes to improve their health status.
During the period of stabilization, patients should begin to reduce their illicit opioid use and experience an elimination of withdrawal symptoms. The practitioner's goal is to help patients find a therapeutic dose of buprenorphine that significantly reduces or eliminates their cravings for illicit opioids. Typical therapeutic doses range from 8 to 24 mg.
The goal is to reduce self-reported cravings and self-reported use of illicit opioids. One benefit worth achieving is a self-reported increase in opioid blockade such that self-administered illicit opioids induce little or no euphoria. A reduction in opioid-positive toxicology specimens confirms a successful direction in treatment. (SAMHSA, p. 56)
On average, buprenorphine doses after induction and titration are usually at least 8 mg per day. However, if patients are continuing to use opioids, consideration should be given to increasing the dose by 4–8 mg (daily dose of 12–16 mg or higher). The US FDA approves dosing to a limit of 24 mg per day, and there is limited evidence regarding the relative efficacy of higher doses. (ASAM, p.34)
The image to the right shows the results from a multi-site randomized clinical trial of buprenorphine dosing over 16 weeks of treatment. The full study is available here.
Consistent with other research, a significant proportion of patients in this study (30-40%) were not retained in treatment. Patients that do not stabilize in a primary care setting should, if possible be referred to specialty treatment settings as described below.
Frequency of Visits
One of the biggest benefits of buprenorphine compared to methadone is that it can be prescribed in office-based settings for at-home administration. Daily dosing and observation are not required. The frequency of visits typically ranges from once every few days to once a month. When patient has demonstrated compliance with the medication and has eliminated illicit opioid use, monthly visits are sufficient for monitoring and disease management. However, even a stable patient can enter a period of instability during which more frequent visits are indicated.
Take for example, the treatment calibration described by physicians working in a "public sector low-threshold" buprenorphine clinic in a New York City public hospital (full study):
Standard 20-min ambulatory visits occurred every 1–4 weeks during the first few months of treatment. Patients stable on maintenance doses were seen at 4–16 week intervals thereafter. Shorter visit intervals were scheduled if illicit opioid, other drug misuse or other problematic behaviors or safety concerns persisted.
Vermont has created a OBOT Stability Index to help determine whether a patients should be scheduled for weekly or monthly office visits. While this screening tool provides a good starting point for assessing stability and visit frequency, each setting will likely want to develop its own protocol for determining the frequency of patient visits.
Re-stabilization and Bi-directional Referral
Chronic disease management always involves treatment calibration. Most of the time, patients receive care in office-based settings. But when symptoms flare up and cannot be managed in an outpatient clinic, patients are hospitalized for acute care. The goal of an acute treatment episode is to stabilize patients sufficiently that their care can be resumed in an outpatient setting. Primary care facilities will ideally partner with specialized treatment settings for the provision of acute care when necessary. Coordination of care can prevent inconsistencies in patient care and facilitate the transfer of the patient back to primary care once the goals of stabilization have been met.
Vermont's OBOT Stability Index can be used at any time in the course of treatment to help determine whether a patient should be transferred to a specialized treatment setting.