Healthy AdultsNCT02194764
An Adherence Tool to Manage Narcotic -Addicted HIV Patients
A study testing Naltrexone and 2-butanol and 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) in people with Healthy Adults, run by Xhale Assurance at 1 site in United States.
Trial summary
The purpose of this study is to develop a cost-effective breath-based medication adherence monitoring system that can monitor whether recovering opiate addicts actually take a specific treatment medication called naltrexone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Naltrexone and 2-butanol and 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and provide written informed consent
- Subject is at least 18 Years of Age
- Subject must be willing to comply with study procedures
Who cannot join
- <18 years
- Subject has a history of opioid use disorder
- current chronic opioid therapy or recent (past week) acute opioid therapy,
- currently pregnant
- contraindications to naltrexone use per FDA label.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Breath-based Naltrexone Adherence Tool to Manage Narcotic-addicted HIV Patients.
The purpose of this study is to develop a cost-effective breath-based medication adherence monitoring system that can monitor whether recovering opiate addicts actually take a specific treatment medication called naltrexone.
Read the detailed description
This study will have two parts. In the first part we will create eight SMART capsule-based naltrexone systems using 4 general types of pharma formulation strategies. Model naltrexone (50mg) formulations containing the GRAS taggant, 2-butanol (40 or 80 mg) will be prepared and preliminary stability studies executed. Type 1 is a hydrophobic system, Type 2 is a hydrophilic system, Type 3 is a reverse micelle system and Type 4 is a water-in-oil microemulsion system. All formulations will be prepared using USP-grade excipients, 2-butanol, naltrexone base and naltrexone HCl. Naltrexone HCl has significant water solubility and will be used in the preparation of formulation types 2 and 4, whereas the more lipid soluble free base of naltrexone will be used in formulation types 1 and 3. Manufacturer's specifications supplied by Capsugel will be used to determine compatibility between the capsule material and the proposed excipients, and will guide capsule selection (gelatin or HPMC).Prepared formulations will be characterized by particle size analysis and analyzed to determine the actual concentrations of naltrexone and 2-butanol. Particle sizing will be accomplished by dynamic light scattering using a 90Plus particle size analyzer. With formulation types 1 and 2, the technique will demonstrate the homogeneity of the mixture and the absence of particulates. With types 3 and 4, particle size distributions will be measured to confirm the presence of monodisperse reverse micelles or nanoscale droplets. The concentration of naltrexone in each final formulation will be verified by Liquid chromatography-mass spectrometry (LC-MS) and /or Ultra Performance Liquid Chromatography (UPLC). The concentration of 2-butanol will be determined by gas chromatography-Mass Spectrometry (GC-MS). Following the initial characterization, the formulations will be stored in sealed vials and placed in ICH standard stability conditions and tested at weekly intervals over 1, 3 and 6 months. The three outstanding formulation candidates will be selected to use in part two of the study.
In the second part the three formulations will be selected from those meeting the criteria for stability, solubility, particle size, color and concentration of 2-butanol in the first part of the study. Each of these formulations will be prepared by a certified pharmacy. In addition to the three selected naltrexone formulations, a fourth dosage form, a capsule-in-capsule (CIC) design, will be prepared in the pharmacy by incorporating 40 or 80 mg (determined from the first part of the study) of 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCI form) in a size 0 double blind hard gel capsule. This capsule-in-capsule design will serve as a formulation-free positive control.
Note: All naltrexone formulations, which will be administered to human subjects, will contain quantities of excipients/components already designated by the FDA as being safe (e.g., inactive ingredient list, permissible daily exposure [PDE], GRAS/direct food additive designation).
- Conditions
- Healthy Adults
- Being tested
- Naltrexone and 2-butanol, 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and 2-butanolDrug
50mg of Naltrexone and 40 or 80 mg of 2-butanol (depending on Stability Formulation in the first part of the study)
2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)Drug
a capsule-in-capsule (CIC) design, will be prepared in the pharmacy by incorporating 40 or 80 mg (determined from the first part of the study) of 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) in a size 0 double blind hard gel capsule.
| Study group | Role | What they receive |
|---|---|---|
| Expirimental Formulation | Experimental | Participants will be administered a single encapsulated dose of the test formulation (Model Naltrexone 50mg containing 2-butanol). Breath samples will be taken over 90 minutes (-5, 0, 5, 10, 20, 40, 60, 90). Subjects will then be randomly crossed over to the four interventions (Formulation 1, Formulation 2, Formulation 3, Formulation-free positive control) three formulations from the first part of the study and a control administration (a capsule-in-capsule design). Receives: Drug: Naltrexone and 2-butanol; Drug: 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of 2-butanol determined by gas chromatography mass spectroscopy (GC-MS)
The primary outcome is to identify three outstanding candidates based on physiochemical principles and the concentration of 2-butanol determined by GC-MS. Following the initial characterization, the formulations will be stored in sealed vials and placed in ICH standard stability conditions and tested at weekly intervals over 1, 3 and 6 months.
Measured: Weekly intervals over 1, 3 and 6 months.
breath concentration versus time
The relationship between the breath concentration (measured via mGC-MOS and gas chromatography mass spectroscopy [GC-MS]) of 2-butanol (taggant) and 2-butanone (metabolite) versus time will be determined after the oral administration of 3 promising naltrexone formulations selected from part of 1 of the study and a positive control.
Measured: -5, 0, 5, 10, 20, 40, 60, 90 min
Secondary outcomes (1)
Breath Pharmacokinetics (Cmax) of the Naltrexone Formulations
The secondary outcome will be to examine the breath pharmacokinetics of 2-butanol, 2-butanone, and cyclopropylcarboxaldehyde [CPCA, a natural metabolite of naltrexone] in human subjects following oral administration of the three selected naltrexone formulations or a positive control containing 2-butanol. Using an endpoint of differing CMAX in a repeated measures design, a difference in means of approximately 150 ppb (parts-per-million based on molar concentration [not mass]), a standard deviation of 75 ppb (based on pilot studies of oral capsules), 8 subjects per group are required (n=8/group) for a ANOVA repeated measures design with maximal tolerated Type I and II errors of 0.05 and 0.20.
Measured: -5, 0, 5, 10, 20, 40, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xhale Assurance
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Donn Dennis, M.D., F.A.H.A., Study director, Xhale Smart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194764
- Sponsor's protocol ID
- 2012115600086371
- Other IDs
- 1R43DA028740-01A1
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Breath-based Naltrexone Adherence Tool to Manage Narcotic-addicted HIV Patients.
- ClinicalTrials.gov ID
- NCT02194764
- Acronym / sponsor ID
- 2012115600086371
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xhale AssuranceIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jul 2014 (estimated)
- 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 purpose of this study is to develop a cost-effective breath-based medication adherence monitoring system that can monitor whether recovering opiate addicts actually take a specific treatment medication called naltrexone.
Detailed description
This study will have two parts. In the first part we will create eight SMART capsule-based naltrexone systems using 4 general types of pharma formulation strategies. Model naltrexone (50mg) formulations containing the GRAS taggant, 2-butanol (40 or 80 mg) will be prepared and preliminary stability studies executed. Type 1 is a hydrophobic system, Type 2 is a hydrophilic system, Type 3 is a reverse micelle system and Type 4 is a water-in-oil microemulsion system. All formulations will be prepared using USP-grade excipients, 2-butanol, naltrexone base and naltrexone HCl. Naltrexone HCl has significant water solubility and will be used in the preparation of formulation types 2 and 4, whereas the more lipid soluble free base of naltrexone will be used in formulation types 1 and 3. Manufacturer's specifications supplied by Capsugel will be used to determine compatibility between the capsule material and the proposed excipients, and will guide capsule selection (gelatin or HPMC).Prepared formulations will be characterized by particle size analysis and analyzed to determine the actual concentrations of naltrexone and 2-butanol. Particle sizing will be accomplished by dynamic light scattering using a 90Plus particle size analyzer. With formulation types 1 and 2, the technique will demonstrate the homogeneity of the mixture and the absence of particulates. With types 3 and 4, particle size distributions will be measured to confirm the presence of monodisperse reverse micelles or nanoscale droplets. The concentration of naltrexone in each final formulation will be verified by Liquid chromatography-mass spectrometry (LC-MS) and /or Ultra Performance Liquid Chromatography (UPLC). The concentration of 2-butanol will be determined by gas chromatography-Mass Spectrometry (GC-MS). Following the initial characterization, the formulations will be stored in sealed vials and placed in ICH standard stability conditions and tested at weekly intervals over 1, 3 and 6 months. The three outstanding formulation candidates will be selected to use in part two of the study.
In the second part the three formulations will be selected from those meeting the criteria for stability, solubility, particle size, color and concentration of 2-butanol in the first part of the study. Each of these formulations will be prepared by a certified pharmacy. In addition to the three selected naltrexone formulations, a fourth dosage form, a capsule-in-capsule (CIC) design, will be prepared in the pharmacy by incorporating 40 or 80 mg (determined from the first part of the study) of 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCI form) in a size 0 double blind hard gel capsule. This capsule-in-capsule design will serve as a formulation-free positive control.
Note: All naltrexone formulations, which will be administered to human subjects, will contain quantities of excipients/components already designated by the FDA as being safe (e.g., inactive ingredient list, permissible daily exposure [PDE], GRAS/direct food additive designation).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expirimental Formulation | Experimental | Drug: Naltrexone and 2-butanol, Drug: 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)Participants will be administered a single encapsulated dose of the test formulation (Model Naltrexone 50mg containing 2-butanol). Breath samples will be taken over 90 minutes (-5, 0, 5, 10, 20, 40, 60, 90). Subjects will then be randomly crossed over to the four interventions (Formulation 1, Formulation 2, Formulation 3, Formulation-free positive control) three formulations from the first part of the study and a control administration (a capsule-in-capsule design). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to understand and provide written informed consent
- Subject is at least 18 Years of Age
- Subject must be willing to comply with study procedures
Key exclusion criteria (5 listed)
- <18 years
- Subject has a history of opioid use disorder
- current chronic opioid therapy or recent (past week) acute opioid therapy,
- currently pregnant
- contraindications to naltrexone use per FDA label.
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 and 2-butanol50mg of Naltrexone and 40 or 80 mg of 2-butanol (depending on Stability Formulation in the first part of the study) | Drug | Expirimental Formulation |
| 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)a capsule-in-capsule (CIC) design, will be prepared in the pharmacy by incorporating 40 or 80 mg (determined from the first part of the study) of 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) in a size 0 double blind hard gel capsule. | Drug | Expirimental Formulation |
Primary outcome
Concentration of 2-butanol determined by gas chromatography mass spectroscopy (GC-MS)
Time frame: Weekly intervals over 1, 3 and 6 months.
The primary outcome is to identify three outstanding candidates based on physiochemical principles and the concentration of 2-butanol determined by GC-MS. Following the initial characterization, the formulations will be stored in sealed vials and placed in ICH standard stability conditions and tested at weekly intervals over 1, 3 and 6 months.
breath concentration versus time
Time frame: -5, 0, 5, 10, 20, 40, 60, 90 min
The relationship between the breath concentration (measured via mGC-MOS and gas chromatography mass spectroscopy [GC-MS]) of 2-butanol (taggant) and 2-butanone (metabolite) versus time will be determined after the oral administration of 3 promising naltrexone formulations selected from part of 1 of the study and a positive control.
1 secondary outcome
Breath Pharmacokinetics (Cmax) of the Naltrexone Formulations
Time frame: -5, 0, 5, 10, 20, 40, 60, 90
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 18 Jul 2014.
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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.
Donn Dennis, M.D., F.A.H.A. study director
Xhale Smart, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone and 2-butanol and 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) in people with Healthy Adults, run by Xhale Assurance at 1 site in United States.
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 3 inclusion and 5 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 18 Jul 2014. 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 United States. 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.
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?
Concentration of 2-butanol determined by gas chromatography mass spectroscopy (GC-MS) (time frame: Weekly intervals over 1, 3 and 6 months.). The study lists 2 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 18 Jul 2014.