Trial Outcomes & Findings for Prevention of Persistent Opioid Use in Mothers (NCT NCT03472521)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

78 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2022-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Gabapentin Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Overall Study STARTED	41	37
Overall Study Received Allocated Intervention	41	37
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Gabapentin Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Overall Study Lost to Follow-up	3	2
Overall Study Discontinued intervention	3	1

Baseline Characteristics

Prevention of Persistent Opioid Use in Mothers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin n=41 Participants Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control n=37 Participants Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Participants who completed the protocol are included in the analysis.

Outcome measures

Outcome measures
Measure	Gabapentin n=35 Participants Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control n=34 Participants Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Time to Opioid Cessation as a Measure of Opioid Utilization	2 weeks Interval 1.0 to 4.0	2 weeks Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who completed the protocol are included in the analysis.

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).

Outcome measures

Outcome measures
Measure	Gabapentin n=35 Participants Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control n=34 Participants Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Pain Report	7 weeks Interval 5.0 to 12.0	12 weeks Interval 6.0 to 12.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who completed the protocol are included in the analysis.

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

Outcome measures

Outcome measures
Measure	Gabapentin n=35 Participants Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Control n=34 Participants Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Functional Recovery	8 weeks Interval 5.0 to 12.0	11 weeks Interval 6.0 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after delivery

PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after delivery

Fitness tracker measured steps

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after delivery

Fitness tracker measured sleep

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after delivery

Fitness tracker measured heart rate

Outcome measures

Outcome data not reported

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pamela Flood, MD, MA

Stanford University

Phone: 201-370-3933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place