What is the recommended treatment regimen for opioid addiction using buprenorphine-naloxone (Suboxone)?

Buprenorphine-Naloxone Treatment Regimen for Opioid Use Disorder

For patients with opioid use disorder, initiate buprenorphine-naloxone only when the patient is in active opioid withdrawal (COWS ≥8), starting with 4-8 mg sublingual based on withdrawal severity, titrating to a target maintenance dose of 16 mg daily, combined with counseling and psychosocial support. 1, 2

Pre-Induction Requirements

Confirm adequate time since last opioid use to avoid precipitated withdrawal: 1

• Short-acting opioids (heroin, morphine IR): >12 hours
• Extended-release formulations (OxyContin): >24 hours
• Methadone maintenance: >72 hours (consider continuing methadone instead due to severe precipitated withdrawal risk) 1

Critical warning: Buprenorphine's high binding affinity and partial agonist properties will induce severe withdrawal if administered before the patient is in active withdrawal. 1

Induction Protocol

Assess Withdrawal Severity Using COWS

Mild withdrawal (COWS <8): 1

• No buprenorphine indicated
• Re-assess patient and COWS in 1-2 hours

Moderate to severe withdrawal (COWS ≥8): 1

• Give buprenorphine-naloxone 4-8 mg sublingual based on severity
• Re-assess after 30-60 minutes
• Target total first-day dose of 16 mg for most patients 1

Maintenance Dosing

Standard maintenance regimen: 1, 2

• Target dose: 16 mg sublingual buprenorphine-naloxone daily
• Dose range: 4-24 mg buprenorphine (with 1-6 mg naloxone in 4:1 ratio) 3, 4, 5
• Administration: Once daily, or can be divided into twice-daily dosing with appropriate dose adjustment 1
• Alternative schedules: Less frequent dosing (e.g., thrice weekly) is possible using multiples of the daily dose to cover the increased interval 3, 4

Discharge Planning and Prescribing

For X-waivered providers (note: waiver requirements have evolved): 1

• Prescribe 16 mg sublingual buprenorphine-naloxone daily for 3-7 days, or until follow-up appointment
• Sample 3-day prescription: Buprenorphine/naloxone 8 mg/2 mg sublingual tablet or film, take 2 tablets/films once daily in AM, dispense #6, no refills

For non-waivered providers: 1

• Patients may return for up to 3 consecutive days for interim treatment

Comprehensive Treatment Requirements

Buprenorphine-naloxone must be part of a complete treatment plan including: 1, 2

• Counseling and psychosocial support
• Behavioral therapies
• Recovery-oriented activities

Essential preventative health measures: 1

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

Monitoring and Follow-Up

Initial phase (first month): 2

• Close monitoring (at least weekly visits)
• Assess compliance with dosing regimen
• Evaluate treatment effectiveness
• Monitor for illicit drug use (urine drug screening)
• Assess for medication toxicity and adverse effects

Stable phase: 2

• Once stable dosage achieved and no illicit drug use detected, less frequent visits appropriate
• Monthly visits reasonable for stable patients making progress
• Continue monitoring for: absence of toxicity, responsible medication handling, compliance with treatment plan, abstinence from illicit drugs

Special Populations

Severe hepatic impairment: 2

• Reduce starting dose and titration increments by half
• Monitor closely for signs of toxicity or overdose due to increased buprenorphine levels

Pregnancy: 1

• Considered a complicating factor requiring specialized management

Discontinuation

When discontinuing treatment: 2

• Taper gradually to reduce withdrawal symptoms
• Advise patients of relapse risk following discontinuation
• Decision should be part of comprehensive treatment plan
• Avoid abrupt cessation 1

Evidence Supporting Efficacy

Buprenorphine-naloxone demonstrates superior outcomes compared to: 1

• Clonidine or lofexidine (less severe withdrawal symptoms, fewer adverse effects, longer treatment retention)
• Similar effectiveness to tapered methadone for opioid withdrawal
• Referral-only or brief intervention approaches (better short-term improvement in treatment and illicit opioid use rates) 1

Safety profile: 4, 6, 5

• Well tolerated with low rates of serious adverse events
• Combination with naloxone reduces (but does not eliminate) abuse potential when taken as prescribed sublingually 3, 4
• Naloxone component causes withdrawal if parenterally administered, deterring diversion 4, 5

Common Pitfalls to Avoid

Do not administer buprenorphine-naloxone to patients: 1

• Not yet in active opioid withdrawal
• Intoxicated with alcohol, benzodiazepines, or other sedatives
• Immediately post-naloxone reversal of overdose
• With serious acute medical illness (heart failure, liver failure, kidney failure, respiratory failure) without appropriate precautions

Special caution with methadone transition: Requires >72 hours since last methadone dose due to risk of severe and prolonged precipitated withdrawal. 1