Pain, AcuteNCT05498025
The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
A study testing Deterra activated charcoal pouch in people with Pain, Acute and Opioid Misuse, run by Geisinger Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Opioid Misuse, Obstetric Pain
- What is being tested?
- Deterra activated charcoal pouch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 29 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
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.
- Being tested
- Deterra activated charcoal pouch
- Keywords
- opioid disposal, drug deactivation, Deterra
- Medical subject headings
- Acute Pain, Opioid-Related Disorders, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deterra activated charcoal pouchOther
drug disposal pouch
| Study group | Role | What they receive |
|---|---|---|
| Activated charcoal pouch | Experimental | 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. Receives: Other: Deterra activated charcoal pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual pouch use
The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start21 Feb 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single arm interventional pilot study.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Paglia, MD PhD, Geisinger Clinic
- Investigators
- Michael J Paglia, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498025
- Sponsor's protocol ID
- 2022-0487
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05498025
- Acronym / sponsor ID
- 2022-0487
- Keywords
- opioid disposal, drug deactivation, Deterra
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single arm interventional pilot study.
| Arm | Type | Receives |
|---|---|---|
| Activated charcoal pouch | Experimental | Other: Deterra activated charcoal pouchThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deterra activated charcoal pouchdrug disposal pouch | Other | Activated charcoal pouch |
Primary outcome
Actual pouch use
Time frame: 30 days
The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Paglia principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deterra activated charcoal pouch in people with Pain, Acute and Opioid Misuse, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual pouch use (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.