CompletedPhase 1

The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations

Canada15 participantsStarted 2019-03-18

Plain-language 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. 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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); * 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; Exclusion Criteria: * Current major Axis I psychiatric disorder for which the subject is currently receiving treatment or which would make study compliance an issue; * Pregn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma concentration of naltrexone and its active metabolite, 6 beta naltrexol

Timeframe: Study day 4 - 10

Trial details

NCT IDNCT03879460

SponsorTimothy Smith

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-03-31

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