Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 42 |
| Updated: | 10/14/2018 |
| Start Date: | May 2016 |
| End Date: | July 2019 |
| Contact: | Pamela Beiler, MSW |
| Email: | beiler@email.unc.edu |
| Phone: | 919-843-3419 |
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.
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.
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.
- 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.
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)
We found this trial at
1
site
321 South Columbia Street
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
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