Oxytocin and Brain Responses in Maternal Addiction (NCT02979093) | Clinical Trial Compass
TerminatedPhase 2
Oxytocin and Brain Responses in Maternal Addiction
Stopped: Unable to recruit proposed study sample size due to COVID restrictions.
United States59 participantsStarted 2017-05-05
Plain-language summary
A prior study by the principal investigator of this project identified dopamine- and oxytocin-related brain pathways that showed a diminished response when addicted mothers viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the investigators plan to examine activation patterns within the salience network, which includes the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and behavioral responses. When administered intranasally, the pilot data has shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.
The purpose of this study is to continue and expand upon the previous investigation of maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate in four study visits over a two-month period.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. are being evaluated for treatment of their addiction or are currently enrolled in treatment programs;
. have an infant \<12 months;
. meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI);
. have a substance abuse history, including use during the most recent pregnancy;
. are recommended at intake for drug-treatment services for substance abuse;
. are 18 years to 40 years old; and
. have been speaking English or enrolled in English-speaking school since age 8.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
Timeframe: 50 minutes after administration of oxytocin or placebo
2
Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)
Timeframe: 50 minutes after administration of oxytocin or placebo
. severe psychiatric or substance-related symptoms requiring in-patient psychiatric hospitalization or detoxification for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the last 30 days;
. past or present diagnosis of schizophrenia or other psychotic disorders;
. metal implants or other contraindications for MRI scanning;
. pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study;
. current pregnancy or plans to become pregnant during the course of the study;
. infants with clinical evidence of in utero drug effects, such as opiate withdrawal symptoms during the neonatal period, facial dysmorphism or intrauterine growth restriction (IUGR) or microcephaly;
. infants with birth weight less than 3 lb. 5 oz.;
. infants who have significant vision, hearing or motor problems (such as cerebral palsy) that cannot be corrected;