NCT03472521

Prevention of Persistent Opioid Use in Mothers

Completed Phase 4 Results posted Last updated 5 May 2022

What this trial tests

Phase 4 trial testing Gabapentin in Opioid Use in 78 participants. Completed in 10 April 2021.

Timeline

17 September 2018

Primary endpoint
2 July 2020

10 April 2021

Quick facts

Lead sponsor	Stanford University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	78
Start date	17 September 2018
Primary completion	2 July 2020
Estimated completion	10 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Gabapentin (Gabapentin) — full drug profile →
• Placebo

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Postpartum Disorder — all drugs for Postpartum Disorder →
• Chronic Pain Syndrome — all drugs for Chronic Pain Syndrome →

Sponsor

Stanford University

Who can join

18 and older, female only, with Opioid Use or Postpartum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Opioid Cessation as a Measure of Opioid Utilization Primary · Up to 12 weeks

Group	Value	95% CI
Gabapentin	2	1 – 4
Control	2	1 – 3

Pain Report Secondary · 12 weeks

Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).

Group	Value	95% CI
Gabapentin	7	5 – 12
Control	12	6 – 12

Functional Recovery Secondary · 12 weeks

Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.

Group	Value	95% CI
Gabapentin	8	5 – 12
Control	11	6 – 12

Sponsor's own description

Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.