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An Adherence Tool to Manage Narcotic -Addicted HIV Patients

NCT02194764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-07-18

No results posted yet for this study

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

Interventions

DRUG

Naltrexone and 2-butanol

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

DRUG

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Xhale Assurance

    lead INDUSTRY

Principal Investigators

  • Donn Dennis, M.D., F.A.H.A. · Xhale Smart, Inc.

Study Design

Allocation
NA
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02194764 on ClinicalTrials.gov