Naltrexone (Oral)
Treatment for Opioid Use Disorders
Typical Dosage: 50 mg orally once daily
Effectiveness
65%
Safety Score
70%
Clinical Trials
16
Participants
5K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
70
DangerousModerateSafe
Treatment Details
Dosage Range
50 mg orally once daily
Time to Effect
Within hours (daily dosing)
Treatment Duration
Daily for at least 12 months
Evidence Quality
MODERATENumber Needed to Treat (NNT)
12(Treat 12 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
120(Treat 120 patients to see 1 additional serious adverse event)
Confidence Score
80%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$480
Monitoring:$2,100
Side Effect Mgmt:$50
Total Annual:$2,630
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
MODERATEICER
$150,000/QALY
QALYs Gained
0.15
Outcome-Based Costs
Cost per Responder
$7,514.29
Cost per Remission
$17,533.33
Comparison vs No treatment
Cost Difference
+$2,630/year
More expensive
QALY Difference
+0.15 QALYs
Better outcomes
Dominance
No dominance
Prescription Access Economics
Annual Societal Loss per Patient
$960
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$600/year
Time Cost
$160/year
Travel + wait time
Insurance Admin Cost
$80/year
Prior auth, claims
Rx Price
$480/year
Potential OTC Price
$360/year
Estimated if OTC available
Risk Assessment
Misuse Risk
LOWMissed Diagnosis Risk
LOWRequires Monitoring
YesNeeds lab work/checkups
Naltrexone (Oral) Outcomes
for Opioid Use Disorders
Efficacy Outcomes
Overall Effectiveness
+65%
Response Rate
+35%
Remission Rate
+15%
Common Side Effects
Nausea
+20%
Headache
+15%
Fatigue
+10%
Hepatotoxicity
+1%
Active Clinical Trials
2 active trials recruiting for Naltrexone (Oral) in Opioid Use Disorders
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
NCT06104280RECRUITING
200 participants
OBSERVATIONAL
Birmingham, United States
Started: Jan 6, 2025
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
NCT07269873RECRUITINGPHASE1
30 participants
INTERVENTIONAL
Miami, United States
Started: Mar 16, 2026
Completed Clinical Trials
11 completed trials for Naltrexone (Oral) in Opioid Use Disorders
Medication-Assisted Treatment for Youth With Substance Use Disorders
NCT02593474COMPLETEDPHASE1
11 participants
INTERVENTIONAL
New York, United States +1 more
Started: Sep 1, 2015
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
NCT03232346COMPLETEDPHASE3
11 participants
INTERVENTIONAL
New York, United States
Started: Aug 1, 2017
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
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
NCT04056182COMPLETEDPHASE2
20 participants
INTERVENTIONAL
New York, United States
Started: Sep 1, 2019
Medication Maintenance Therapy in Community Pharmacy Settings
NCT03766893COMPLETEDEARLY_PHASE1
11 participants
INTERVENTIONAL
Providence, United States
Started: Sep 1, 2018
Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone
NCT04762537COMPLETEDNA
415 participants
INTERVENTIONAL
Orlando, United States +5 more
Started: Mar 16, 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
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
NCT03718104COMPLETED
46 participants
OBSERVATIONAL
Boston, United States +1 more
Started: Dec 1, 2018
Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
NCT00142948COMPLETEDPHASE2
301 participants
INTERVENTIONAL
Saint Petersburg, Russia
Started: Feb 1, 2006
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
NCT01218984COMPLETEDPHASE2
27 participants
INTERVENTIONAL
Started: Mar 1, 2002
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
NCT01380093COMPLETEDPHASE1
80 participants
INTERVENTIONAL
Salt Lake City, United States
Started: Feb 1, 2011