Opioid-use DisorderPhase 1NCT03851731
Evaluation of Intranasal Naltrexone and Naloxone
A Phase 1 study testing Naltrexone, Naloxone and Naltrexol in people with Opioid-use Disorder, run by National Institute on Drug Abuse (NIDA).
Trial summary
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Naltrexone, Naloxone and Naltrexol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2015to 7 Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 to 55 years of age, inclusive.
- Provide written informed consent.
- Body mass index (BMI) ranging from 18 to 30 kg/m2, inclusive.
- Adequate venous access.
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
- Agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
Who cannot join
- Contact site for more information
About this study
Official title: Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
- Conditions
- Opioid-use Disorder
- Being tested
- Naltrexone, Naloxone, Naltrexol
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Vivitrol
Intranasal spray
NaloxoneDrug
Also called Narcan
Intranasal spray
NaltrexolDrug
Intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered Receives: Drug: Naltrexone |
| Naloxone | Experimental | Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered Receives: Drug: Naloxone |
| Naltrexol | Experimental | Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered Receives: Drug: Naltrexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter [maximum serum concentration - Cmax]
The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination.
Measured: 12 days
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination.
Measured: 12 days
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination.
Measured: 12 days
Secondary outcomes (6)
Adverse Events
To assess and document any adverse events measures
Measured: 15 days
Vital Sign - Heart Rate
To assess and document heart rate before and after intranasal dosing
Measured: 12 days
Vital Sign - Blood pressure (diastolic)
To assess and document blood pressure (diastolic) before and after intranasal dosing
Measured: 12 days
Vital Sign - Blood pressure (systolic)
To assess and document blood pressure (systolic) before and after intranasal dosing
Measured: 12 days
Vital Sign - Respiration Rate
To assess and document respiration rate before and after intranasal dosing
Measured: 12 days
Electrocardiogram
Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start5 Oct 2015
- Primary completion7 Nov 2015
- Study completion7 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nora Chiang, PhD, Study chair, NIH / NIDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851731
- Sponsor's protocol ID
- Naltrexone-Ph1a-001
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03851731
- Acronym / sponsor ID
- Naltrexone-Ph1a-001
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 7 Nov 2015 (actual)
- Study completion
- 7 Nov 2015 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: NaltrexoneSubject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
| Naloxone | Experimental | Drug: NaloxoneSubject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
| Naltrexol | Experimental | Drug: NaltrexolSubject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females 18 to 55 years of age, inclusive.
- Provide written informed consent.
- Body mass index (BMI) ranging from 18 to 30 kg/m2, inclusive.
- Adequate venous access.
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
Key exclusion criteria (1 listed)
- Contact site for more information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: VivitrolIntranasal spray | Drug | Naltrexone |
| NaloxoneAlso: NarcanIntranasal spray | Drug | Naloxone |
| NaltrexolIntranasal spray | Drug | Naltrexol |
Primary outcome
Pharmacokinetic parameter [maximum serum concentration - Cmax]
Time frame: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
Time frame: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
Time frame: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination.
6 secondary outcomes
Adverse Events
Time frame: 15 days
Vital Sign - Heart Rate
Time frame: 12 days
Vital Sign - Blood pressure (diastolic)
Time frame: 12 days
Vital Sign - Blood pressure (systolic)
Time frame: 12 days
Vital Sign - Respiration Rate
Time frame: 12 days
Electrocardiogram
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Chiang, PhD study chair
NIH / NIDA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone, Naloxone and Naltrexol in people with Opioid-use Disorder, run by National Institute on Drug Abuse (NIDA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter [maximum serum concentration - Cmax] (time frame: 12 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.