What is the recommended protocol for initiating Suboxone (buprenorphine and naloxone) treatment?

How to Initiate Suboxone (Buprenorphine/Naloxone)

Initiate buprenorphine/naloxone only when the patient is in active opioid withdrawal, confirmed by Clinical Opiate Withdrawal Scale (COWS) score >8, and start with 4-8 mg sublingual based on withdrawal severity, targeting a total first-day dose of 16 mg for most patients. 1

Pre-Initiation Requirements

Confirm Adequate Time Since Last Opioid Use

• Short-acting opioids (heroin, morphine IR): >12 hours since last use 1
• Extended-release formulations (OxyContin): >24 hours since last use 1
• Methadone maintenance: >72 hours since last use (consider continuing methadone instead) 1

Assess Withdrawal Severity Using COWS

• COWS <8 (mild or less): No buprenorphine indicated; reassess in 1-2 hours 1
• COWS ≥8 (moderate to severe): Proceed with buprenorphine initiation 1

Critical Warning: Administering buprenorphine before adequate withdrawal will cause precipitated withdrawal due to buprenorphine's high receptor affinity displacing full agonist opioids while providing less activation. 1, 2 This risk is particularly severe when transitioning from methadone. 1

Standard Induction Protocol

Initial Dosing

• First dose: 4-8 mg sublingual buprenorphine/naloxone based on withdrawal severity 1
• Reassess after 30-60 minutes for response 1
• Target total first-day dose: 16 mg for most patients 1

Maintenance Dosing

• Standard maintenance range: 16 mg daily (can range from 4-24 mg daily) 1, 3
• At 16 mg and above, buprenorphine occupies approximately 95% of mu-opioid receptors 4
• Dosing can be administered once daily or split into twice-daily dosing if needed 1

Discharge Planning

• X-waivered prescribers: Prescribe 16 mg sublingual buprenorphine/naloxone daily for 3-7 days or until follow-up 1
• Non-X-waivered prescribers: Patients may return for up to 3 consecutive days for interim treatment 1

Alternative: Low-Dose (Microdosing) Initiation

For patients unable to tolerate withdrawal or using high-potency synthetic opioids (fentanyl), consider low-dose initiation starting at very low doses (0.5-2 mg) and gradually titrating up over several days while continuing full opioid agonist use. 5

Low-Dose Initiation Principles

• Start at very low buprenorphine doses (0.5-2 mg sublingual) 5
• Gradually increase dose over days, not hours 5, 6
• Continue full opioid agonist (even if illicit) during initial titration 5
• Pause or delay dose increases if any withdrawal symptoms occur 5
• This method avoids precipitated withdrawal by slowly displacing full agonists 5, 6

Transdermal Bridge Method

• Apply transdermal buprenorphine patches for 48 hours while continuing opioid use 7
• Transition to sublingual buprenorphine/naloxone on day 3 7
• This method minimizes withdrawal and precipitated withdrawal risk 7

Pre-Treatment Assessment

Screen for Opioid Use Disorder

• Conduct addiction assessment before initiating treatment 1
• Many chronic pain criteria can mimic OUD, risking false-positives 1
• Consider consultation with addiction specialist if diagnosis unclear 1

Address Comorbidities

• Assess and treat depression, anxiety, and insomnia before and during treatment 1
• Screen for cardiac conditions requiring ECG monitoring 8
• Avoid QT-prolonging agents due to contraindication with buprenorphine 8, 2

Critical Safety Considerations

Contraindications and Warnings

• Never administer to intoxicated patients (alcohol, benzodiazepines, sedatives) 1
• Avoid in post-overdose reversal with naloxone until adequate withdrawal develops 1
• Contraindicated with QT-prolonging medications due to cardiac arrhythmia risk 8, 2
• Exercise extreme caution in elderly, debilitated, or respiratory disease patients 9

Monitoring Requirements

• Monitor for respiratory depression, especially during initiation and dose increases 9
• Watch for signs of serotonin syndrome if combined with serotonergic agents 8, 2
• ECG monitoring needed for patients with cardiac risk factors 8

Harm Reduction and Preventive Care

Strongly consider offering at discharge: 1

• Overdose prevention education
• Take-home naloxone kit
• Hepatitis C and HIV screening
• Reproductive health counseling

Common Pitfalls to Avoid

• Do not initiate without objective withdrawal: Using COWS score prevents precipitated withdrawal 1
• Do not abruptly discontinue: This constitutes patient abandonment and increases overdose risk 1
• Do not combine with additional opioids for pain: This undermines treatment goals; use multimodal non-opioid analgesia instead 2
• Do not use fixed-interval dosing in pediatrics until proper inter-dose interval established by observation 9

Treatment Philosophy

Buprenorphine/naloxone combined with counseling and behavioral therapies provides a "whole-patient" approach that has demonstrated effectiveness and saves lives. 1 This medication-assisted treatment approach shows better short-term improvement in treatment retention and reduced illicit opioid use compared to referral or brief intervention alone. 1