Naltrexone (Extended-Release Injectable)
Treatment for Opioid Use Disorders
Typical Dosage: 380 mg intramuscular injection once monthly
Effectiveness
80%
Safety Score
68%
Clinical Trials
16
Participants
10K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
68
DangerousModerateSafe
Treatment Details
Dosage Range
380 mg intramuscular injection once monthly
Time to Effect
Within hours of injection (lasts 1 month)
Treatment Duration
Monthly injections for at least 12 months
Evidence Quality
HIGHNumber Needed to Treat (NNT)
7(Treat 7 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
100(Treat 100 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$16,800
Monitoring:$3,000
Side Effect Mgmt:$100
Total Annual:$19,900
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
MODERATEICER
$90,000/QALY
QALYs Gained
0.35
Outcome-Based Costs
Cost per Responder
$36,181.82
Cost per Remission
$66,333.33
Comparison vs Buprenorphine/Naloxone
Cost Difference
+$13,800/year
More expensive
QALY Difference
-0.05 QALYs
Worse outcomes
Dominance
No dominance
Naltrexone (Extended-Release Injectable) Outcomes
for Opioid Use Disorders
Efficacy Outcomes
Overall Effectiveness
+80%
Response Rate
+55%
Remission Rate
+30%
Common Side Effects
Nausea
+15%
Headache
+15%
Injection site pain/tenderness
+40%
Fatigue
+10%
Hepatotoxicity
+1%
Active Clinical Trials
6 active trials recruiting for Naltrexone (Extended-Release Injectable) in Opioid Use Disorders
Extended Release Naltrexone Versus Extended Release Buprenorphine with Individuals Leaving Jail
NCT04408313ACTIVE NOT RECRUITINGPHASE2, PHASE3
240 participants
INTERVENTIONAL
Baltimore, United States
Started: Oct 28, 2020
BIOPIN 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
NCT07064564NOT YET RECRUITINGPHASE1
33 participants
INTERVENTIONAL
Started: Feb 1, 2026
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
NCT04464980ACTIVE NOT RECRUITINGPHASE2
1.52K participants
INTERVENTIONAL
Little Rock, United States +20 more
Started: Jun 8, 2021
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
NCT07269873NOT YET RECRUITINGPHASE1
30 participants
INTERVENTIONAL
Started: Jan 13, 2026
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
NCT04480554RECRUITINGPHASE2
225 participants
INTERVENTIONAL
Philadelphia, United States +1 more
Started: Jan 30, 2023
The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
NCT04245423ACTIVE NOT RECRUITINGNA
567 participants
INTERVENTIONAL
Philadelphia, United States
Started: Dec 15, 2020
Completed Clinical Trials
10 completed trials for Naltrexone (Extended-Release Injectable) in Opioid Use Disorders
Long Acting Naltrexone for Opioid Addiction: Focus on Sustained Abstinence and Recovery
NCT03647774COMPLETEDPHASE4
317 participants
INTERVENTIONAL
Loerenskog, Norway
Started: Aug 1, 2018
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
NCT05053503COMPLETEDNA
108 participants
INTERVENTIONAL
Rancho Mirage, United States +3 more
Started: May 27, 2022
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
NCT01908062COMPLETEDPHASE3
51 participants
INTERVENTIONAL
Chicago, United States +1 more
Started: Jun 1, 2014
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
NCT03275350COMPLETEDPHASE2, PHASE3
114 participants
INTERVENTIONAL
Tarzana, United States +4 more
Started: Feb 5, 2018
Cocaine Use Reduction With Buprenorphine
NCT01402492COMPLETEDPHASE2, PHASE3
302 participants
INTERVENTIONAL
Los Angeles, United States +10 more
Started: Sep 1, 2011
EXHIT ENTRE Comparative Effectiveness Trial
NCT04345718COMPLETEDPHASE2, PHASE3
344 participants
INTERVENTIONAL
New Haven, United States +5 more
Started: Aug 9, 2021
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
NCT04219540COMPLETEDPHASE4
675 participants
INTERVENTIONAL
New Haven, United States +5 more
Started: Jan 7, 2021
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
NCT02537574COMPLETEDPHASE3
380 participants
INTERVENTIONAL
Oceanside, United States +19 more
Started: Aug 1, 2015
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
NCT01218984COMPLETEDPHASE2
27 participants
INTERVENTIONAL
Started: Mar 1, 2002
The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
NCT01556425COMPLETEDPHASE2
84 participants
INTERVENTIONAL
Baltimore, United States
Started: May 1, 2012