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4mg Intranasal Naltrexone with Intravail for Opioid Use Disorder

Phase 1
Waitlist Available
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma Concentration (AUC 0-inf)
Plasma Concentration (AUC 0-t)
Plasma Concentration (Cmax)
+1 more
Secondary study objectives
12-lead electrocardiogram
Adverse Events
Nasal Irritation Scoring
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: 50mg NaltrexoneExperimental Treatment1 Intervention
Administer 50mg formulation orally
Group II: 4mg Intranasal Naltrexone with IntravailExperimental Treatment2 Interventions
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
Group III: 4mg Intranasal NaltrexoneExperimental Treatment1 Intervention
Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
Group IV: 2mg Intramuscular NaltrexoneExperimental Treatment1 Intervention
Administer 2 mg formulation intramuscularly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,589 Previous Clinical Trials
3,328,503 Total Patients Enrolled
Nora Chiang, PhDStudy ChairNational Institute on Drug Abuse (NIDA)
1 Previous Clinical Trials
12 Total Patients Enrolled
~1 spots leftby Dec 2025
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