Environment Analysis Inside an Investigational Prescription Bottle

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Other: Regular prescription Bottle; Other: Research Bottle

• Registration Number: NCT03752411
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Study Start: 2018-12-05
• Primary Completion: 2022-11-05
• Status Verified: 2023-11
• Study Completion: 2023-11-05
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular prescription Bottle	Regular prescription Bottle	This group will have medication dispensed in a regular prescription bottle
Research Bottle	Research Bottle	This group will have medication dispensed in a research bottle.

Primary Outcome Measures

Name	Time	Method
total nausea scale	day 90	On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
total medication dose	day 90	pain medication dose (mg)
total vomiting scale	day 90	On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
total type of bowel movement	day 90	choose one of the following: hard, soft, loose
total Pain scale	day 90	On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
overall satisfaction with pain control	day 90	0-10 scale where 0 is dissatisfied and 10 is very satisfied
total sedation scale	day 90	On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
total bowel movements	day 90	number of bowel movements (whole number)

Secondary Outcome Measures

Name	Time	Method
Barretts impulsivity questionnaire	day 90	Measures impulsivity behavior core (number 0-120) where 0-40 is low levels of impulsivity, 41-80 is moderate levels of impulsivity, and 81-120 is high levels of impulsivity
opioid related behavior in treatment questionnaire	day 90	Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse
prescribed opioids difficulty scale	day 90	measures opioid management score (number 0-32) where 0-10 is low difficulty, 11-21 is moderate difficulty and 22-32 is high levels of difficulty

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States