CompletedNCT03918850MOMsUpdated Jun 4, 2026Results posted

Medication Treatment for Opioid Use Disorder in Expectant Mothers

A Phase 3 interventional study of Buprenorphine Injection and Buprenorphine Sublingual Product in Opioid-Related Disorders, Drug Addiction and Pregnancy Related, sponsored by T. John Winhusen, PhD. Completed at 12 sites in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by T. John Winhusen, PhD · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 140
Allocation: Randomized
Ages: 18 Years to 41 Years
Sex: Female

Study summary

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

Read the detailed description

This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.

Conditions studied

Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
Neonatal Abstinence Syndrome
Neonatal Opioid Withdrawal Syndrome
Drug Abuse in Pregnancy

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Keywords

CTN-0080
clinical trials network
medication assisted treatment

Who can participate

Ages eligible: 18 Years to 41 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Potential participants must:

be 18-41 years of age
be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA \< 12 weeks and is not planning to terminate the pregnancy
have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD
be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits
be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS
be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
be able to understand the study, and having understood, provide written informed consent in English

Exclusion criteria

Exclusion Criteria:

Potential participants must not:

have a physiological dependence on alcohol or sedatives requiring medical detoxification
have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
- Suicidal or homicidal ideation requiring immediate attention
- Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
- aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
- serum creatinine greater than 1.5X upper limit of normal
- total bilirubin greater than 1.5X upper limit of normal
be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
be currently receiving methadone or naltrexone for the treatment of OUD;
be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;
be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 140 participants (actual)

Study arms

Experimental
BUP-XR
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Injection
Active comparator
BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Sublingual Product

Interventions

DrugBuprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Also known as: CAM2038
DrugBuprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Also known as: Subutex, Suboxone

What researchers measure

Primary outcomes

Percentage of Illicit Opioid-negative Urine Samples During Pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks

Secondary outcomes

Percentage of Illicit Opioid-negative Urine Samples Postpartum
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Time frame: Delivery through 12 months postpartum
Percentage of Days With Study Medication Adherence During Pregnancy
Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Days With Study Medication Adherence - Postpartum
Adherence to treatment from delivery through 12 months postpartum, checked weekly.
Time frame: Delivery through 12 months postpartum
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.
Time frame: Delivery through 12 months postpartum
Opioid Craving Scale - Pregnancy
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Opioid Craving Scale - Postpartum
The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Adequacy of Prenatal Care Utilization Index
The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.
Time frame: At delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported.
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Total Days of Neonatal Opioid Treatment During the Hospital Stay
Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Infant Hospital Length of Stay
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Custody at Discharge
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Child Protective Services Open Case
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Ages and Stages Questionnaire, Third Edition (ASQ-3)
To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.
Time frame: 12 months postpartum

Results

Posted Jun 4, 2026

Participant flow

Participant flow — Overall Study
Milestone	BUP-XR	BUP-SL
Started	69	71
Completed	57	57
Not completed	12	14

Outcome measures

PrimaryPercentage of Illicit Opioid-negative Urine Samples During Pregnancy

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Time frame:: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Reported as:: Mean · % Illicit opioid-negative urine samples

Percentage of Illicit Opioid-negative Urine Samples During Pregnancy
% Illicit opioid-negative urine samples	BUP-XR	BUP-SL
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy	82.5 ± 4.2	72.6 ± 4.2

SecondaryPercentage of Illicit Opioid-negative Urine Samples Postpartum

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.

Time frame:: Delivery through 12 months postpartum
Reported as:: Mean · % Illicit opioid-negative urine samples

Percentage of Illicit Opioid-negative Urine Samples Postpartum
% Illicit opioid-negative urine samples	BUP-XR	BUP-SL
Percentage of Illicit Opioid-negative Urine Samples Postpartum	60.2 ± 4.2	59.5 ± 4.1

SecondaryPercentage of Days With Study Medication Adherence During Pregnancy

Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Time frame:: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Reported as:: Mean · percentage of expected days adherent

Percentage of Days With Study Medication Adherence During Pregnancy
percentage of expected days adherent	BUP-XR	BUP-SL
Percentage of Days With Study Medication Adherence During Pregnancy	84.4 ± 3.1	84.9 ± 3.0

SecondaryPercentage of Days With Study Medication Adherence - Postpartum

Adherence to treatment from delivery through 12 months postpartum, checked weekly.

Time frame:: Delivery through 12 months postpartum
Reported as:: Mean · percentage of expected days adherent

Percentage of Days With Study Medication Adherence - Postpartum
percentage of expected days adherent	BUP-XR	BUP-SL
Percentage of Days With Study Medication Adherence - Postpartum	69.3 ± 4.3	75.5 ± 4.2

SecondaryPercentage of Drug and Alcohol-negative Urine Samples During Pregnancy

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.

Time frame:: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Reported as:: Mean · Percentage of negative urine samples

Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
Percentage of negative urine samples	BUP-XR	BUP-SL
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy	58.8 ± 3.4	52.2 ± 3.4

SecondaryPercentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase

Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.

Time frame:: Delivery through 12 months postpartum
Reported as:: Mean · Percentage of negative urine samples

Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
Percentage of negative urine samples	BUP-XR	BUP-SL
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase	34.7 ± 3.3	35.0 ± 3.2

SecondaryOpioid Craving Scale - Pregnancy

The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.

Time frame:: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Reported as:: Mean · score on a scale

Opioid Craving Scale - Pregnancy
score on a scale	BUP-XR	BUP-SL
Opioid Craving Scale - Pregnancy	1.9 ± 0.2	2.5 ± 0.2

SecondaryOpioid Craving Scale - Postpartum

The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported

Time frame:: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Reported as:: Mean · score on a scale

Opioid Craving Scale - Postpartum
score on a scale	BUP-XR	BUP-SL
Opioid Craving Scale - Postpartum	1.5 ± 0.2	1.7 ± 0.2

SecondaryAdequacy of Prenatal Care Utilization Index

The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.

Time frame:: At delivery
Reported as:: Number · percentage of participants

Adequacy of Prenatal Care Utilization Index
percentage of participants	BUP-XR	BUP-SL
Inadequate	36.7 ± 8.9	19.4 ± 6.7
Intermediate	13.3 ± 6.3	16.7 ± 6.3
Adequate	23.3 ± 7.9	13.9 ± 5.8
Adequate Plus	26.7 ± 8.2	50.0 ± 8.5

SecondaryShort Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy

Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.

Time frame:: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Reported as:: Mean · score on a scale

Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
score on a scale	BUP-XR	BUP-SL
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy	5.6 ± 0.5	6.2 ± 0.5

SecondaryShort Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum

Time frame:: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Reported as:: Mean · score on a scale

Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
score on a scale	BUP-XR	BUP-SL
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum	4.1 ± 0.5	5.3 ± 0.5

SecondaryOpioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms

Use of opioid medication for NOWS symptoms will be abstracted from the medical record.

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Mean · Total amount of morphine for NOWS-mg

Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Total amount of morphine for NOWS-mg	BUP-XR	BUP-SL
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms	10.0 ± 3.2	10.4 ± 3.2

SecondaryTotal Days of Neonatal Opioid Treatment During the Hospital Stay

Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Mean · Days of opioid treatment

Total Days of Neonatal Opioid Treatment During the Hospital Stay
Days of opioid treatment	BUP-XR	BUP-SL
Total Days of Neonatal Opioid Treatment During the Hospital Stay	10.9 ± 2.2	14.8 ± 3.0

SecondaryInfant Hospital Length of Stay

Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Mean · Hospital length of stay, days

Infant Hospital Length of Stay
Hospital length of stay, days	BUP-XR	BUP-SL
Infant Hospital Length of Stay	8.5 ± 0.9	9.5 ± 1.0

SecondaryNeonatal Opioid Withdrawal Syndrome (NOWS) Peak Score

NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Mean · score on a scale

Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
score on a scale	BUP-XR	BUP-SL
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score	10.4 ± 0.8	10.0 ± 0.9

SecondaryCustody at Discharge

For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Number · % of participants with maternal custody

Custody at Discharge
% of participants with maternal custody	BUP-XR	BUP-SL
Custody at Discharge	90.9 ± 3.5	89.7 ± 3.7

SecondaryChild Protective Services Open Case

Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.

Time frame:: Neonate discharge from hospital, typically within 1 month postpartum
Reported as:: Number · % Case with child protective services

Child Protective Services Open Case
% Case with child protective services	BUP-XR	BUP-SL
Child Protective Services Open Case	32.8 ± 5.9	38.8 ± 6.0

SecondaryAges and Stages Questionnaire, Third Edition (ASQ-3)

To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.

Time frame:: 12 months postpartum
Reported as:: Number · % infants w/ dev. issues

Ages and Stages Questionnaire, Third Edition (ASQ-3)
% infants w/ dev. issues	BUP-XR	BUP-SL
Ages and Stages Questionnaire, Third Edition (ASQ-3)	17.3 ± 5.2	15.4 ± 5.0

Adverse events

Collected over Consent through 1 year postpartum, up to 1 year and 8 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BUP-XR	0/69 (0%)	9/69 (13%)	49/69 (71%)
BUP-SL	0/71 (0%)	27/71 (38%)	59/71 (83.1%)
BUP-XR - Neonates	0/67 (0%)	9/67 (13.4%)	—
BUP-SL - Neonates	1/70 (1.4%)	11/70 (15.7%)	—

Most frequent serious events

Showing 10 of 67

Most frequent serious events
Event	BUP-XR	BUP-SL	BUP-XR - Neonates	BUP-SL - Neonates
Gestational hypertensionPregnancy, puerperium and perinatal conditions	0/69	4/71	0/67	0/70
Pre-EclampsiaPregnancy, puerperium and perinatal conditions	3/69	3/71	0/67	0/70
OverdoseInjury, poisoning and procedural complications	3/69	0/71	0/67	0/70
Suicidal ideationPsychiatric disorders	0/69	3/71	0/67	0/70
Weight gain poorMetabolism and nutrition disorders	0/69	0/71	2/67	0/70
PyelonephritisInfections and infestations	2/69	1/71	0/67	0/70
Drug use disorderPsychiatric disorders	0/69	2/71	0/67	0/70
COVID-19Infections and infestations	0/69	2/71	0/67	1/70
HospitalisationSurgical and medical procedures	0/69	2/71	0/67	0/70
Pyloric StenosisCongenital, familial and genetic disorders	—	—	1/67	0/70

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	BUP-XR	BUP-SL	BUP-XR - Neonates	BUP-SL - Neonates
COVID-19Infections and infestations	9/69	15/71	—	—
VomitingGastrointestinal disorders	12/69	7/71	—	—
Upper Respiratory Tract InfectionInfections and infestations	10/69	11/71	—	—
NauseaGastrointestinal disorders	10/69	5/71	—	—
Urinary Tract InfectionInfections and infestations	4/69	9/71	—	—
HeadacheNervous system disorders	6/69	8/71	—	—
ConstipationGastrointestinal disorders	6/69	7/71	—	—
GastroenteritisInfections and infestations	6/69	3/71	—	—
Abdominal painGastrointestinal disorders	2/69	6/71	—	—
Tooth abscessInfections and infestations	1/69	6/71	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	BUP-XR	BUP-SL	Total
Mean	31.1 ± 4.6	31.4 ± 4.7	31.2 ± 4.6

Sex: Female, Male
Sex: Female, Male(Participants)	BUP-XR	BUP-SL	Total
Female	69	71	140
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	BUP-XR	BUP-SL	Total
Hispanic or Latino	4	6	10
Not Hispanic or Latino	65	65	130
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	BUP-XR	BUP-SL	Total
American Indian or Alaska Native	0	3	3
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	3	7	10
White	59	57	116
More than one race	5	2	7
Unknown or Not Reported	0	2	2

Opioid Craving Scale
Opioid Craving Scale(score on a scale)	BUP-XR	BUP-SL	Total
Mean	2.7 ± 2.5	3.7 ± 3.0	3.2 ± 2.8

Short Opioid Withdrawal Scale
Short Opioid Withdrawal Scale(score on a scale)	BUP-XR	BUP-SL	Total
Mean	7.0 ± 7.0	5.8 ± 6.6	6.4 ± 6.8

Study locations

12 sites

Gateway Community Services
Jacksonville, Florida 32204, United States
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts 02114, United States
Boston Medical Center
Boston, Massachusetts 02118, United States
University of New Mexico Milagro Clinic
Albuquerque, New Mexico 87106, United States
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio 45229, United States
CODA, Inc.
Portland, Oregon 97214, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania 15213, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah 84108, United States
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington 98107, United States
Marshall Health MARC Program
Huntington, West Virginia 25701, United States

References and documents

Publications

Winhusen TJ, Lofwall MR, Kropp F, Lewis D, Smid MC, Young JL, Hodgkins C, Krans EE, Hansen Z, Wachman EM, Schiff DM, Guille C, Rudolf V, Chowdhury T, Leeman L, Lewis M, Matthews AG, Cochran G, King J, Wilder C, Rosa C. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):533-543. doi: 10.1001/jamainternmed.2026.0057. PubMed 41837971 ↗
Krans EE, Lewis D, Douaihy A, Lofwall MR, Kropp F, Martin PR, Sanghani RS, Cottrell JN, Winhusen TJ. Cigarette use and smoking cessation goals among pregnant women with opioid use disorder. J Subst Use Addict Treat. 2025 Dec 20:209865. doi: 10.1016/j.josat.2025.209865. Online ahead of print. PubMed 41429292 ↗
Cash E, Cochran G, Smid MC, Charles JE, Humiston G, Wei Y, Mauerman N, Carlston K, Broussard G, Sengpraseut B, Martin PR, Winhusen TJ. Overdose risk profiles in pregnancy: Latent class analysis of pregnant individuals with opioid use disorder. J Subst Use Addict Treat. 2025 Sep 25:209809. doi: 10.1016/j.josat.2025.209809. Online ahead of print. PubMed 41015387 ↗
Snyder AM, Math S, Campbell K, Schiff DM, Wheeler A, Carlston K, Gordon AJ, Winhusen TJ, Cochran G, Smid MC. Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study. Subst Use Addctn J. 2025 Oct;46(4):1040-1046. doi: 10.1177/29767342251334490. Epub 2025 Jul 11. PubMed 40643178 ↗
Winhusen TJ, Kropp F, Greenfield SF, Krans EE, Lewis D, Martin PR, Gordon AJ, Davies TH, Wachman EM, Douaihy A, Parker K, Xin X, Jalali A, Lofwall MR. Trauma Prevalence and Its Association With Health-related Quality of Life in Pregnant Persons With Opioid Use Disorder. J Addict Med. 2025 Jan-Feb 01;19(1):20-25. doi: 10.1097/ADM.0000000000001366. Epub 2024 Aug 6. PubMed 39105509 ↗
Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4. PubMed 37023858 ↗

Study documents

Protocol and statistical analysis plan · May 21, 2021
Informed consent form · Nov 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.

Supporting information: Study protocol

Registry details

Key details

Study ID: NCT03918850
Lead sponsor: T. John Winhusen, PhD
Collaborators: National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
Responsible party: T. John Winhusen, PhD (Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati) — Sponsor-investigator
First posted: Apr 18, 2019
Start date: Jul 21, 2020
Primary completion: Jan 31, 2025
Completion: Jan 31, 2025
Results posted: Jun 4, 2026
Last update: Jun 4, 2026

Study contacts

T. John Winhusen, PhD

principal investigator · University of Cincinnati

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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