Purpose

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • chronic pain > 3 months duration
  • major source of pain is due to low back pain diagnosis
  • prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen
  • Last urine drug study was done between 6-12 months ago
  • will have a return to clinic visit in 3 months

Exclusion Criteria

  • concurrent use of other opioids
  • use of intrathecal device
  • use of spinal cord stimulator
  • presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer related surgery
  • dementia
  • illiteracy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Research Bottle
This group will have medication dispensed in a research bottle.
  • Other: Research Bottle
    The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Placebo Comparator
Regular prescription Bottle
This group will have medication dispensed in a regular prescription bottle
  • Other: Regular prescription Bottle
    This will test if the research bottle changes behavior relative to the research bottle

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Denise Wilkes, MD
409-772-1221

More Details

NCT ID
NCT03752411
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Maria Garcia, MS
409-789-2308
mdgarcia@utmb.edu

Detailed Description

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. The participant will be asked to keep the medication in the bottle and to remove each pill immediately before taking it.

The participant will not store medications in pill organizers, other pill bottles, pockets, purses, etc. The participant will keep a record of when the participant removes a pill from the bottle and takes it. Certain aspects of this study will be withheld from the participant to preserve the integrity of the study. This information will be revealed at the conclusion of the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.