Opioid IntoxicationPhase 1TEST CANADANCT03879460
The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
A Phase 1 study testing Naltrexone Hydrochloride in people with Opioid Intoxication, run by Timothy Smith at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Intoxication
- What is being tested?
- Naltrexone Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 18 Mar 2019to 31 Mar 2019
- 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
- Non pregnant
- between 18 and 55 years;
- Body weight with a BMI range of 18.5 to 27.0 [or weight within 15% of ideal weight for subject's height and frame (to be based on Metropolitan Life Insurance Company weight tables);
- Healthy, with normal findings in the physical examination and vital signs (BP between 100-140/60-90 mmHg, HR between 60 to 90 beats/min, respiration between 12 to 24 breaths/min, SpO2 >90% breathing room air) and no clinically-significant findings in a 12-lead electrocardiogram;
- No clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant;
- Non-smoking (i.e. having no history of tobacco, or other substance, smoking for greater than or equal to 12 months, and not having smoked within the past year by self-report);
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- Negative tests for smoking tobacco (urine cotinine test), alcohol (urine test), hepatitis B- surface antigen, hepatitis C antibody, tuberculin skin-prick test at screening;
- Negative urine screen for drugs of abuse;
- Willing and able to communicate well with the investigator and clinic staff, comply with the study procedure and schedule, and provide written informed consent;
- Able to understand the requirements of the study and sign informed consent;
Who cannot join
- Current major Axis I psychiatric disorder for which the subject is currently receiving treatment or which would make study compliance an issue;
- Pregnant. A test will be available for prospective participants;
- Breast-feeding women;
- Any condition or therapy which, in the opinion of the investigator, may be significantly worsened by the administration of naltrexone or is likely to interfere with the successful collection of the measures required;
- Acute disease at the time of enrolment (i.e. presence of a moderate or severe illness or infection with or without a fever);
- Febrile illness (oral temperature >37.6º C at the time of drug administration);
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- Unstable chronic illnesses;
- Chronic liver, renal or inflammatory bowel disease or collagen vascular disease;
- Clinically significant elevation of ALT and/or AST;
- Active neurological disorder;
- Clinically significant uncontrolled illness or clinically significant surgery within 4 weeks prior to administration of study drug;
- Cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin;
- History of any clinical laboratory abnormality deemed significant by the Principal Investigator;
- History of serious adverse reaction or hypersensitivity to any drug;
- Bleeding tendency resulting from disease or medication rendering blood collection or the injection itself unsafe (use of antiplatelet agents is allowed);
- Coagulation disorders or receiving anticoagulant therapy;
- Inability to tolerate abstinence from caffeine for 24 hours prior to and during the study treatment phase;
- Consumption of alcohol within 24 hours prior to dosing and during the treatment phase;
- History of significant alcohol or drug abuse within one year prior to the screening visit or regular use of alcohol within six months prior to the screening visit (more than 14 units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]);
- Use of soft drugs (such as marijuana) within three months prior to the screening visit or hard drugs (such as cocaine, phencyclidine or crack) within one year prior to the screening visit or positive urine drug screen at screening or positive urine drug screen at screening;
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- 50 mL to 300 mL of whole blood within 30 days;
- 301 mL to 500 mL of whole blood within 45 days; or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Any known or suspected allergy to any constituent of naltrexone;
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigators, contraindicates the subject's participation inthis study;
- Use of any investigational or non-registered drug or participation in an investigational study within 30 days prior to administration of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. The physical and mental/cognitive performance assessments will be conducted at various times prior, during and following drug administration. Daily blood draws will also be taken to assess blood levels of naltrexone and active metabolites for correlation to performance parameters associated with the Military Skill \& Tasked Based Fitness Test.
- Conditions
- Opioid Intoxication
- Being tested
- Naltrexone Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HydrochlorideDrug
50 mg per os naltrexone hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Open label Receives: Drug: Naltrexone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of naltrexone and its active metabolite, 6 beta naltrexol
Measured: Study day 4 - 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start18 Mar 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid IntoxicationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label safety assessment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Smith
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Timothy Smith, Canadian Department of National Defence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879460
- Sponsor's protocol ID
- 2018-044
- Acronym
- TEST CANADA
- Status last verified
- May 2019
- First submitted
- 14 Mar 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
- ClinicalTrials.gov ID
- NCT03879460
- Acronym / sponsor ID
- TEST CANADA / 2018-044
- Conditions
- Opioid Intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Timothy SmithOther government
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 18 Mar 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.
The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. The physical and mental/cognitive performance assessments will be conducted at various times prior, during and following drug administration. Daily blood draws will also be taken to assess blood levels of naltrexone and active metabolites for correlation to performance parameters associated with the Military Skill \& Tasked Based Fitness Test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label safety assessment
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: Naltrexone HydrochlorideOpen label |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Non pregnant
- between 18 and 55 years;
- Body weight with a BMI range of 18.5 to 27.0 [or weight within 15% of ideal weight for subject's height and frame (to be based on Metropolitan Life Insurance Company weight tables);
- Healthy, with normal findings in the physical examination and vital signs (BP between 100-140/60-90 mmHg, HR between 60 to 90 beats/min, respiration between 12 to 24 breaths/min, SpO2 >90% breathing room air) and no clinically-significant findings in a 12-lead electrocardiogram;
- No clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant;
Key exclusion criteria (27 listed)
- Current major Axis I psychiatric disorder for which the subject is currently receiving treatment or which would make study compliance an issue;
- Pregnant. A test will be available for prospective participants;
- Breast-feeding women;
- Any condition or therapy which, in the opinion of the investigator, may be significantly worsened by the administration of naltrexone or is likely to interfere with the successful collection of the measures required;
- Acute disease at the time of enrolment (i.e. presence of a moderate or severe illness or infection with or without a fever);
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 |
|---|---|---|
| Naltrexone Hydrochloride50 mg per os naltrexone hydrochloride | Drug | Open Label |
Primary outcome
Plasma concentration of naltrexone and its active metabolite, 6 beta naltrexol
Time frame: Study day 4 - 10
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 17 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone Hydrochloride in people with Opioid Intoxication, run by Timothy Smith at 1 site in Canada.
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 10 inclusion and 27 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 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Plasma concentration of naltrexone and its active metabolite, 6 beta naltrexol (time frame: Study day 4 - 10). 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 17 May 2019.