An Adherence Tool to Manage Narcotic -Addicted HIV Patients

NCT02194764 | Completed

• 2 other identifiers: 20121156000863711R43DA028740-01A1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  -5, 0, 5, 10, 20, 40, 60, 90 min

Secondary Outcomes (1)

• Breath Pharmacokinetics (Cmax) of the Naltrexone Formulations

  -5, 0, 5, 10, 20, 40, 60, 90

Study Arms (1)

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).

Drug: Naltrexone and 2-butanol; Drug: 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)

Interventions

Naltrexone and 2-butanol DRUG

50mg of Naltrexone and 40 or 80 mg of 2-butanol (depending on Stability Formulation in the first part of the study)

Expirimental Formulation

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.

Expirimental Formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Xhale Assurance: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Naltrexone; 2-butanol

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Donn Dennis, M.D., F.A.H.A.

  Xhale Smart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 18, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

US (1)