Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inhaled Oxytocin and HPA Axis Reactivity

NCT03593473

Depression, Postpartum Anxiety Disorders Stress, Psychological

COMPLETED PHASE2

Intranasal Oxytocin and Maternal Neglect

NCT02737436

Maternal Behavior

COMPLETED NA

Oxytocin for Couples Conflict Resolution

NCT02941692

Substance Misuse Interpersonal Conflict Neuroendocrine Reactivity

COMPLETED PHASE2

The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy

NCT00563966

Effects of Smoking on Infant

UNKNOWN

The Influence of Oxytocin on Pair-bonding and Emotion Regulation

NCT02501837

Healthy

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participation for mothers when they are 3-6 months postpartum includes:

* Visit 1: Questionnaires and interviews about participants' health, pregnancy, moods, psychological history and drug use during pregnancy and postpartum.
* Visit 2: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, instruction re: using nasal spray (oxytocin or placebo) \& self-administration of first nasal spray dose, followed by 90 minutes of monitoring.
* At-home nasal spray: Twice daily (before breakfast and supper) nasal spray self-administration for 14 days.
* Visit 3: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, interviews and questionnaires about mothers' experience with the nasal spray, and changes in mood or physical discomfort during the 2-weeks when taking the nasal spray.
* 3 telephone interviews while subjects are taking nasal spray, and 1 post-trail telephone follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Abuse Problem Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Syntocinon treatment

Syntocinon spray, 24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).

Group Type EXPERIMENTAL

Syntocinon treatment

Intervention Type DRUG

24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).

Placebo

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Syntocinon treatment

24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).

Intervention Type DRUG

Placebo

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nasal Oxytocin treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 3-6 months postpartum at start of testing
* Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology)
* Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk)
* Healthy singleton pregnancy
* English fluency that will allow informed consent

Exclusion Criteria

* Pregnancy or plans to become pregnant during participation in the study
* Not using effective birth control methods to prevent pregnancy
* Breastfeeding for any infant milk feedings
* Mother is not currently living with the infant during the trial period
* Multiple birth (twin, triplet or greater)

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes