CClinicalTrials.gg
CompletedNCT05498025Updated Jan 19, 2024

The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery

An interventional study of Deterra activated charcoal pouch in Pain, Acute, Opioid Misuse and Obstetric Pain, sponsored by Geisinger Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation.

Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery.

Methods: This is a prospective single arm interventional pilot study.

02

Conditions studied

  • Pain, Acute
  • Opioid Misuse
  • Obstetric Pain
  • Cesarean Section Complications

Keywords

  • opioid disposal
  • drug deactivation
  • Deterra
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18+ at time of enrollment, per ERM
  • Delivered ≥26.0 weeks, per ERM
  • Status post low transverse cesarean delivery, per ERM
  • Physically located on labor \& delivery and is postpartum day #1 or #2 at time of enrollment, per ERM
  • Opioid prescription has been sent (per ERM) or will be sent (per obstetric team).

Exclusion criteria

Exclusion criteria:

  • Positive urine toxicology anytime in pregnancy for non-prescription opioids, fentanyl, amphetamines, benzodiazepines, cannabinoids, LSD, or cocaine, per ERM.
  • Buprenorphine or methadone Rx, per ERM
  • Patient preferred communication language not English, per ERM
  • Documented history, per ERM:

    • Cannabinoid use disorder
    • Hypnotic use disorder
    • Opioid use disorder
    • Stimulant use disorder
    • Fibromyalgia
    • Sickle cell anemia
    • Lumbar disc herniation
    • Multiple sclerosis
    • Trigeminal neuralgia
    • Active cancer
    • Complex regional pain syndrome
    • Systemic lupus erythematosus
    • Rheumatoid arthritis
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Activated charcoal pouch

    The patients in this arm will receive an activated charcoal pouch (Deterra Medium Pouch, UPC #: 850006727001, Verde Environmental Technologies, Minnetonka, MN) for disposal of their opioids after their cesarean delivery pain has resolved.

    Other: Deterra activated charcoal pouch

Interventions

  • OtherDeterra activated charcoal pouch

    drug disposal pouch

06

What researchers measure

Primary outcomes

  1. Actual pouch use

    The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)

    Time frame: 30 days

07

Study locations

1 site
  • Geisinger Medical Center
    Danville, Pennsylvania 17822, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05498025
Lead sponsor
Geisinger Clinic
Responsible party
Michael J. Paglia, MD PhD (Principal Investigator, Geisinger Clinic) — Principal investigator
First posted
Aug 11, 2022
Start date
Feb 21, 2023
Primary completion
Jul 29, 2023
Completion
Jul 29, 2023
Last update
Jan 19, 2024

Study contacts

Michael J Paglia
principal investigator · Geisinger Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion