What treatment plan is recommended for patients with opioid use disorder or alcohol use disorder now that Trexzone is FDA-approved?

Treatment Recommendations for Opioid Use Disorder and Alcohol Use Disorder

Patients with opioid use disorder or alcohol use disorder should be offered timely initiation of FDA-approved medications—specifically buprenorphine, methadone, or extended-release naltrexone for opioid use disorder, and extended-release naltrexone or oral naltrexone for alcohol use disorder—regardless of other treatment plans, as these medications reduce substance use, improve mortality, and enhance quality of life. 1

FDA-Approved Medications for Opioid Use Disorder

The three FDA-approved medications for opioid use disorder all reduce nonmedical opioid use and risk of HIV and HCV acquisition 1:

• Buprenorphine (partial mu-opioid agonist): Available as sublingual tablets/films, typically combined with naloxone (Suboxone) to prevent diversion 1
• Methadone (full mu-opioid agonist): Restricted to federally regulated narcotic treatment programs 1
• Extended-release naltrexone (opioid antagonist): Monthly injection (Vivitrol) or daily oral formulation 1

Longer-term or maintenance treatment is strongly recommended over brief medication tapers, as short treatment periods are associated with high relapse rates and increased overdose risk after discontinuation. 1, 2

FDA-Approved Medications for Alcohol Use Disorder

For alcohol use disorder, FDA-approved options include 1:

• Extended-release naltrexone (monthly injection)
• Oral naltrexone (daily dosing)

These medications reduce alcohol consumption and HIV acquisition risk 1.

Practical Implementation Algorithm

For Opioid Use Disorder:

Step 1: Confirm active opioid withdrawal before initiating buprenorphine 1:

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

Step 2: Assess withdrawal severity using Clinical Opiate Withdrawal Scale (COWS) 1:

• COWS <8 (mild): No buprenorphine indicated initially; reassess in 1-2 hours
• COWS ≥8 (moderate to severe): Give buprenorphine 4-8 mg sublingual based on severity

Step 3: Target total dose of 16 mg sublingual buprenorphine for most patients on day one 1

Step 4: Prescribe maintenance therapy for 3-7 days or until follow-up, with typical dosing of 16 mg daily 1

Critical Caution with Buprenorphine:

Never administer buprenorphine to patients not yet in active withdrawal, as its high binding affinity and partial agonist properties will induce severe precipitated withdrawal 1. This risk is particularly pronounced when transitioning from methadone to buprenorphine 1.

For Alcohol Use Disorder:

Initiate extended-release naltrexone or oral naltrexone without delay 1. Unlike opioid use disorder, there is no requirement to wait for withdrawal symptoms before starting naltrexone for alcohol use disorder.

Integration with Other Medical Care

Medications for substance use disorders have few clinically significant drug-drug interactions with antiretroviral therapy or hepatitis C direct-acting antivirals; therefore, these treatments should never be withheld from patients receiving HIV or HCV treatment. 1

Medication treatment of opioid use disorder and alcohol use disorder improves antiretroviral therapy adherence and viral suppression in HIV-positive patients 1.

Essential Adjunctive Services

All patients should receive integrated care including 1:

• Harm reduction services: Naloxone dispensation, safe use education, fentanyl and xylazine test strips, referral to syringe service programs 1
• Behavioral therapies: Counseling and psychotherapeutic approaches alongside pharmacotherapy 1
• Accessible service delivery: Telehealth, extended hours, mobile clinics, pharmacy delivery services, peer support staff 1
• Overdose prevention education and take-home naloxone kits 1
• Screening for HIV, hepatitis C, and reproductive health counseling 1

Common Pitfalls to Avoid

Do not restrict pharmacotherapy only to patients whose goal is abstinence. Even reductions in substance use frequency or amount have important health benefits, including decreased risks of cancer, hypertension, overdose, and infectious disease transmission 1.

Do not delay medication initiation while waiting for behavioral therapy enrollment or other treatment components 1. Timely medication initiation is critical and should occur regardless of HIV, HCV, or other treatment plans 1.

Monitor for hepatotoxicity with naltrexone: Baseline and periodic liver function tests (every 3-6 months) are recommended, as naltrexone has been associated with hepatic injury at supratherapeutic doses 1.

Screen for co-occurring mental health disorders, as anxiety, depression, bipolar disorder, PTSD, and personality disorders are significantly more common in patients with substance use disorders 1.

Treatment Duration

Patients should be encouraged to continue pharmacotherapy indefinitely, as discontinuation substantially increases relapse risk and overdose mortality due to decreased opioid tolerance 1, 2. Longer treatment duration allows restoration of social connections and is associated with superior outcomes 2.