What is the recommended treatment protocol for Suboxone (buprenorphine/naloxone) for opioid use disorder?

Suboxone Treatment Protocol for Opioid Use Disorder

Core Recommendation

For patients with opioid use disorder, clinicians should offer or arrange medication-assisted treatment with buprenorphine/naloxone (Suboxone) combined with behavioral therapies, as this represents evidence-based standard of care that reduces mortality and improves treatment outcomes. 1

Patient Assessment and Diagnosis

• Assess for opioid use disorder using DSM-5 criteria before initiating treatment 1
• Evaluate the type of opioid dependence (short-acting like heroin vs. long-acting like methadone), time since last use, and degree of dependence 2
• Assess risk factors including history of overdose, concurrent benzodiazepine use, and comorbid psychiatric conditions 1
• Do not dismiss patients from your practice due to substance use disorder, as this represents patient abandonment and compromises safety 1

Induction Protocol

For Short-Acting Opioids (Heroin, Oxycodone, Hydrocodone)

• Administer the first dose only when objective signs of moderate withdrawal appear, not less than 4 hours after last opioid use 2
• Start with 8 mg buprenorphine on Day 1, followed by 16 mg on Day 2 2
• Titrate rapidly to adequate treatment dose using 2-4 mg increments to minimize dropout during induction 2

For Long-Acting Opioids (Methadone)

• Wait until objective signs of moderate withdrawal appear, generally not less than 24 hours after last dose 2
• Patients on methadone >30 mg daily are at higher risk for precipitated withdrawal during induction 2
• Use caution as withdrawal symptoms are more likely and prolonged compared to short-acting opioid users 2

Maintenance Treatment

• The recommended target maintenance dose is 16 mg daily of buprenorphine/naloxone, with a typical range of 4-24 mg daily 2
• Buprenorphine/naloxone combination tablets are preferred over buprenorphine alone for maintenance due to reduced diversion potential 2
• Dosages above 24 mg have not demonstrated additional clinical advantage 2
• There is no maximum duration of maintenance treatment—patients may require indefinite treatment and should continue as long as they are benefiting 2

Long-Acting Injectable Formulation (Sublocade)

• Stabilize patients on 8-24 mg daily sublingual buprenorphine for minimum 7 consecutive days before transitioning 3, 4
• Administer first two monthly doses at 300 mg, followed by maintenance doses of 100 mg monthly 3, 4
• Do not attempt to remove long-acting injectable buprenorphine after administration due to risks of surgical complications, infection, and tissue damage 3

Behavioral Therapy Integration

• Always combine medication-assisted treatment with behavioral therapies—buprenorphine alone without psychosocial support is insufficient 1, 2
• Provide or arrange for evidence-based psychotherapies such as cognitive behavioral therapy 1
• No clinical studies support buprenorphine as the sole treatment component 2

Monitoring Requirements

• Review prescription drug monitoring program (PDMP) data at treatment initiation and periodically (every prescription to every 3 months) 1
• Perform urine drug testing before starting therapy and at least annually during maintenance 1
• Evaluate benefits and harms every 3 months or more frequently 1
• Monitor closely after first dose for precipitated withdrawal, especially in patients recently using full opioid agonists 3, 4

Critical Safety Considerations

Contraindications and Drug Interactions

• Avoid concurrent prescribing of benzodiazepines whenever possible due to fatal respiratory depression risk 1
• Concomitant use with QT-prolonging agents is contraindicated 3, 4
• Be aware of interactions causing QT prolongation, serotonin syndrome, paralytic ileus, or precipitated withdrawal 3, 4

Naloxone Co-Prescription

• Offer naloxone for overdose prevention to all patients with opioid use disorder, particularly those with history of overdose, higher doses (≥50 MME/day), or concurrent benzodiazepine use 1

Special Populations

• For pregnant women with opioid use disorder, offer buprenorphine (without naloxone) or methadone, as this improves maternal outcomes 1
• For perioperative patients, be cautious as buprenorphine's high receptor binding affinity may interfere with pain management 4

Provider Requirements

• Physicians must obtain a waiver from SAMHSA to prescribe buprenorphine in office-based settings 1
• Training and certification are required before prescribing buprenorphine products 3
• Physicians prescribing opioids in communities with insufficient treatment capacity should strongly consider obtaining this waiver 1
• No waiver is needed to prescribe naltrexone for opioid use disorder 1

Referral Pathways

• If unable to provide treatment directly, arrange for care with substance use disorder specialists or SAMHSA-certified opioid treatment programs 1
• Coordinate ongoing care and ensure follow-up with treatment providers 1
• Utilize SAMHSA's buprenorphine physician locator and Provider Clinical Support System resources 1

Common Pitfalls to Avoid

• Do not initiate buprenorphine before withdrawal symptoms appear, as this precipitates severe withdrawal 2
• Avoid gradual induction over many days, as this increases dropout rates 2
• Do not provide multiple refills early in treatment without appropriate follow-up 2
• Sporadic opioid use in first few months is common—address with increased visit frequency and intensified behavioral therapy rather than discontinuing treatment 5
• Do not cut, chew, or swallow sublingual tablets—they must dissolve completely under the tongue 2