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 range18 Years – 40 Years
SexFEMALE
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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.
✓. have an infant \<12 months of age;
Exclusion criteria
✕. 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;
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
✕. 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;