Substance Abuse ProblemPhase 1NOXNCT02872467
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
A Phase 1 study testing Syntocinon treatment in people with Substance Abuse Problem and Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem, Pregnancy
- What is being tested?
- Syntocinon treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC School of Medicine, Medical School Wing D
Chapel Hill, North Carolina, 27599-7175
About this study
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.
Read the detailed description
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
- Substance Abuse Problem, Pregnancy
- Being tested
- Syntocinon treatment, Placebo
- Keywords
- Cocaine, Mothers, Pregnant women, Postpartum women, Oxytocin, Substance use disorders, Substance abuse, Prenatal substance use, stress
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon treatmentDrug
Also called Nasal Oxytocin 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).
PlaceboOther
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
| Study group | Role | What they receive |
|---|---|---|
| Syntocinon treatment | Experimental | 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). Receives: Drug: Syntocinon treatment |
| Placebo | Placebo comparator | Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
Measured: 2 weeks
Secondary outcomes (3)
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.
Measured: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.
Measured: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2023
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse ProblemStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Karen Grewen, Ph.D., Principal investigator, UNC School of Medicine, Dept. of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872467
- Sponsor's protocol ID
- 14-3053
- Acronym
- NOX
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
- ClinicalTrials.gov ID
- NCT02872467
- Acronym / sponsor ID
- NOX / 14-3053
- Conditions
- Substance Abuse Problem, Pregnancy
- Keywords
- Cocaine, Mothers, Pregnant women, Postpartum women, Oxytocin, Substance use disorders, Substance abuse, Prenatal substance use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- May 2016
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syntocinon treatment | Experimental | Drug: Syntocinon treatmentSyntocinon 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). |
| Placebo | Placebo comparator | Other: PlaceboPlacebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntocinon treatmentAlso: Nasal Oxytocin treatment24 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). | Drug | Syntocinon treatment |
| PlaceboPlacebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. | Other | Placebo |
Primary outcome
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
Time frame: 2 weeks
3 secondary outcomes
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.
Time frame: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.
Time frame: 2 weeks
The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Grewen, Ph.D. principal investigator
UNC School of Medicine, Dept. of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Syntocinon treatment in people with Substance Abuse Problem and Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.