What is the recommended treatment regimen for a patient with opioid use disorder, specifically using Suboxone (buprenorphine and naloxone)?

Suboxone (Buprenorphine/Naloxone) Treatment for Opioid Use Disorder

For patients with opioid use disorder, initiate buprenorphine/naloxone (Suboxone) at 4-8 mg sublingual once the patient is in moderate to severe withdrawal (COWS score >8), then titrate to a target maintenance dose of 16 mg daily, combined with behavioral therapies. 1

Patient Selection and Assessment

Confirm opioid use disorder using DSM-5 criteria before initiating treatment. 1 Key diagnostic features include:

• Problematic pattern of opioid use causing clinically significant impairment 1
• At least two defined criteria occurring within a year 1
• Assessment should evaluate risk of relapse and expected withdrawal severity 2

Medication-assisted treatment with buprenorphine/naloxone is more effective than clonidine, lofexidine, or no medication in reducing withdrawal symptoms, preventing relapse, and improving treatment retention. 1, 3

Induction Protocol

Timing Requirements

The patient must be in active opioid withdrawal before administering the first dose to avoid precipitated withdrawal. 1 Confirm adequate time since last opioid use:

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

Assess withdrawal severity using the Clinical Opiate Withdrawal Scale (COWS). 1

Dosing Schedule

For moderate to severe withdrawal (COWS >8), administer 4-8 mg sublingual buprenorphine/naloxone based on withdrawal severity. 1 The standard induction approach:

• Initial dose: 4-8 mg sublingual 1
• Reassess after 30-60 minutes 1
• Target total first-day dose: 8-16 mg 1, 4

Titrate to a maintenance dose of 16 mg daily, as this dose is clearly superior to placebo and as effective as methadone. 4 Dosages of at least 7 mg per day show effectiveness, but 16 mg daily demonstrates optimal outcomes 4

The maximum recommended daily dose range is 4-24 mg (buprenorphine component). 5, 4

Alternative Micro-Dosing Approach

For patients unable to achieve adequate withdrawal before induction (particularly those using fentanyl or on prescribed opioids), consider micro-dosing:

• Day 1: 0.5 mg once daily 6
• Day 2: 0.5 mg twice daily 6
• Day 3: 1 mg twice daily 6
• Day 4: 2 mg twice daily 6
• Day 5: 3 mg twice daily 6
• Day 6: 4 mg twice daily 6
• Day 7: 12 mg once daily, discontinue all other opioids 6

This approach allows concurrent use of other opioids during induction and avoids precipitated withdrawal. 6

Maintenance Treatment

Prescribe buprenorphine/naloxone (not buprenorphine alone) for outpatient treatment due to abuse-deterrent properties. 1 The naloxone component:

• Has no clinically significant effect when taken sublingually as prescribed 3
• Causes withdrawal if injected parenterally, reducing diversion risk 3

Less frequent dosing schedules (thrice weekly) are effective and improve patient satisfaction. 3 When dosing less than daily, administer multiples of the daily dose to cover the increased interval 5

Combine medication treatment with behavioral therapies, as this combination reduces opioid misuse and increases treatment retention. 1, 7

Long-Acting Injectable Formulation

For patients stabilized on transmucosal buprenorphine, transition to long-acting injectable buprenorphine (Sublocade) with initial 300 mg monthly doses for two months, followed by 100 mg monthly maintenance doses. 2

Requirements before transitioning:

• Stabilization on 8-24 mg daily sublingual/buccal buprenorphine for minimum 7 consecutive days 2
• Patient not experiencing withdrawal symptoms 2
• Comfortable on oral buprenorphine dose 2

Critical Safety Considerations

Avoid concomitant use of buprenorphine with QT-prolonging agents, as this is contraindicated. 1, 2

Multiple drug-drug interactions can cause QT-interval prolongation, serotonin syndrome, paralytic ileus, reduced analgesic effect, or precipitation of withdrawal symptoms. 1, 2

For pregnant women with opioid use disorder, prescribe buprenorphine without naloxone, as this improves maternal outcomes. 1, 2

Monitoring and Follow-Up

Schedule frequent follow-up visits initially, documenting relapses, cravings, withdrawal symptoms, and conducting random urine drug testing. 4 Sporadic opioid use in the first few months is common and should trigger:

• Increased visit frequency 4
• More intensive behavioral therapy engagement 4
• Pill or wrapper counts 4
• State prescription drug database checks 4

Combine urine drug testing with prescription drug monitoring program data and clinical assessment using DSM-5 criteria for ongoing monitoring. 7

Prescriber Requirements

Physicians must obtain a Drug Addiction Treatment Act of 2000 waiver from SAMHSA to prescribe buprenorphine for opioid use disorder in office-based settings. 1, 2 This waiver requires:

• Specific training completion 2
• Notification to SAMHSA of intent to prescribe 4

Physicians prescribing opioids in communities with insufficient treatment capacity should strongly consider obtaining this waiver. 1, 2

Special Clinical Situations

Perioperative Management

For patients on buprenorphine undergoing surgery, individualize the decision to continue or hold based on daily dose, indication (pain vs. dependency), relapse risk, and expected postoperative pain level. 1 The prescribed regimen should reflect a patient-centered final decision 1

Patients Failing High-Dose Opioid Therapy

For patients on high-dose opioid therapy with poor pain control, poor functioning, and poor response to taper but without opioid use disorder, consider a trial of buprenorphine/naloxone. 1 This approach is warranted because:

• Neither opioid escalation nor reduction appears viable 1
• Buprenorphine/naloxone may reduce urges for dose escalation 1
• The combination is demonstrably safer than high doses of mu agonists 1

Common Pitfalls

Do not administer buprenorphine before adequate withdrawal is established, as the high binding affinity and partial agonist properties will displace full agonists and precipitate severe withdrawal. 1

Do not prescribe buprenorphine alone (without naloxone) for outpatient treatment, as this increases diversion and abuse potential. 1, 5

Do not discontinue treatment abruptly; if withdrawal is indicated, use gradual dose reduction over rapid cessation. 5

Recognize that many DSM-5 criteria for opioid use disorder can occur in chronic pain patients, risking false-positives—consider addiction specialist consultation when diagnosis is uncertain. 1