What is the protocol for initiating Suboxone (buprenorphine/naloxone) therapy in a patient with severe opioid use disorder?

From the Guidelines

Starting a patient on Suboxone (buprenorphine/naloxone) therapy for severe opioid use disorder requires careful planning and monitoring, with a recommended initial dose of 2-4 mg sublingually, and a target maintenance dose of 16 mg daily, as supported by a recent meta-analysis 1. To initiate therapy, ensure the patient is in mild to moderate withdrawal before starting treatment to avoid precipitated withdrawal.

• Verify the patient hasn't used short-acting opioids for at least 12-24 hours or long-acting opioids for 36-48 hours before induction.
• Use a validated opioid withdrawal scale to confirm the presence of at least mild withdrawal symptoms.
• Begin with an initial dose of 2-4 mg sublingually, and observe for 1-2 hours.
• If withdrawal symptoms persist, administer an additional 2-4 mg. The total first-day dose typically ranges from 8-16 mg, and on day two, give the total day one dose as a single dose, with potential adjustments based on the patient's response.
• Patients should be enrolled in a comprehensive treatment program including counseling and behavioral therapy.
• Regular monitoring for compliance, side effects, and continued substance use is essential, as noted in a study on substance use disorders in pregnancy 1. Suboxone works by partially activating opioid receptors (reducing cravings and withdrawal) while blocking other opioids from binding, making it effective for both detoxification and long-term maintenance therapy for opioid dependence, as described in a primary care approach to substance misuse 1.

From the FDA Drug Label

2.3 Induction Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid products), the time since last opioid use, and the degree or level of opioid dependence Patients Dependent on Heroin or Other Short-acting Opioid Products At treatment initiation, the first dose of Buprenorphine Sublingual Tablets should be administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred.

To start a patient on Suboxone therapy for severe opioid use disorder,

• Assess the type of opioid dependence and the time since last opioid use.
• Administer the first dose of Buprenorphine Sublingual Tablets when objective signs of moderate opioid withdrawal appear.
• Initiate treatment with a dose of 2 mg to 4 mg, and titrate to clinical effectiveness as rapidly as possible.
• Monitor the patient closely during the induction phase. 2

From the Research

Initiating Suboxone Therapy for Severe Opioid Use Disorder

To start a patient on Suboxone (buprenorphine) therapy for severe opioid use disorder, several factors should be considered:

• Patient beliefs about the efficacy and safety of buprenorphine, as well as perceived consistency with being drug-free, can predict stated patient preferences for a particular medication-assisted treatment (MAT) or for no MAT 3
• Buprenorphine is a recommended medication for the treatment of opioid use disorder, with proven benefits to the individual and society, and should be considered as part of an integrated treatment plan that includes psychosocial interventions 4
• The choice of buprenorphine as a treatment option should be based on the needs of the individual, characteristics of the medication, clinical efficacy, safety, patient preference, side effects, pharmacological interactions, quality of life, dose titration potential, and outcomes 4

Buprenorphine Initiation Strategies

Different buprenorphine initiation strategies have been proposed, including:

• Traditional initiation, which involves a period of mild-to-moderate withdrawal from opioids before transitioning to buprenorphine 5
• Microdosing, which involves concomitant administration of small doses of buprenorphine with opioids to avoid unwanted withdrawal associated with buprenorphine initiation 5, 6
• Bridging with a buprenorphine patch, which has been reported in some case series 6

Efficacy and Safety of Buprenorphine Initiation Strategies

The efficacy and safety of buprenorphine initiation strategies have been evaluated in several studies:

• A systematic review of 7 observational studies, 1 feasibility study, and 39 case reports/series found that traditional initiation and microdosing initiation were effective for patients with opioid use disorder, with a high success rate of rotation to sublingual buprenorphine 5
• A systematic review of case reports/series found that buprenorphine initiation strategies that omit prerequisite withdrawal have emerged, but the evidence is of low quality and there is an unmet need for controlled studies to inform their efficacy and safety compared with traditional strategies 6

Considerations for Buprenorphine Treatment

When considering buprenorphine treatment for opioid use disorder, several factors should be taken into account:

• Barriers, challenges, risks, and efficacy of buprenorphine treatment compared with other treatments 7
• Different formulations of buprenorphine, including newer long-acting injectable formulations that may decrease the risk of diversion and improve adherence 7