Oxytocin and Brain Responses in Maternal Addiction
Maternal Behavior, Maternal Addiction
About this trial
This is an interventional basic science trial for Maternal Behavior focused on measuring maternal drug addiction, mother-infant attachment, intranasal oxytocin, unresolved trauma, maternal brain responses, mother-infant synchrony
Eligibility Criteria
Inclusion Criteria for addiction sample:
Drug-addicted subjects will be English speaking adult women who:
- 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.
Inclusion Criteria for non-addicted mothers (controls):
Control subjects will be English-speaking adult women who:
- have an infant <12 months of age;
- do not meet criteria for past or present drug abuse or dependence;
- are 18 years to 40 years old; and
- have been speaking English or enrolled in English-speaking school since age 8.
Exclusion Criteria for addiction sample:
Potential drug-addicted subjects will be ineligible if they have:
- 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;
- mothers who have significant vision or hearing problems that cannot be corrected;
- out-of-home placement of infant for the past month or more than 50% of child's life;
- delivered more than one baby during most recent pregnancy (twins, triplets, etc.).
- exclusively breastfeeding
Exclusion criteria for non-addicted mothers:
Potential control subjects will be ineligible if they have:
- positive drug toxicology screen at any point in the study;
- drug abuse or dependence based on MINI in the past year or lifetime;
- use of tobacco products in the past 2 years;
- current hazardous alcohol use as ascertained by AUDIT score > 8;
- present or past history of ambulatory detoxification;
- severe psychiatric symptoms requiring inpatient psychiatric hospitalization for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the past 30 days;
- past or present diagnosis of schizophrenia or other psychotic disorders;
- metal implants or other contraindications for MRI scanning;
- current pregnancy or plans to become pregnant during the course of the study;
- infants with birth weight less than 3 lb. 5 oz.;
- infants who have significant vision, hearing or motor problems that cannot be corrected (such as cerebral palsy);
- mothers who have significant vision or hearing problems that cannot be corrected;
- out-of-home placement of infant for the past month or more than 50% of child's life; and
- delivered more than one baby during most recent pregnancy (twins, triplets, etc.).
- exclusively breastfeeding
Sites / Locations
- Yale Child Study Center
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Other
Other
Addicted
Control
The addiction group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.
The control group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.