Oxytocin and Brain Responses in Maternal Addiction

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lane Strathearn, MBBS PhD; University of Iowa
• Collaborator: Yale University
• Treatments: Oxytocin

Criteria

Inclusion Criteria for addiction sample:

Drug-addicted subjects will be English speaking adult women who:

1. are being evaluated for treatment of their addiction or are currently enrolled in treatment programs;

2. have an infant <12 months;

3. meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI);

4. have a substance abuse history, including use during the most recent pregnancy;

5. are recommended at intake for drug-treatment services for substance abuse;

6. are 18 years to 40 years old; and

7. 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:

1. have an infant <12 months of age;

2. do not meet criteria for past or present drug abuse or dependence;

3. are 18 years to 40 years old; and

4. 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:

1. 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;

2. past or present diagnosis of schizophrenia or other psychotic disorders;

3. metal implants or other contraindications for MRI scanning;

4. pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study;

5. current pregnancy or plans to become pregnant during the course of the study;

6. 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;

7. infants with birth weight less than 3 lb. 5 oz.;

8. infants who have significant vision, hearing or motor problems (such as cerebral palsy) that cannot be corrected;

9. mothers who have significant vision or hearing problems that cannot be corrected;

10. out-of-home placement of infant for the past month or more than 50% of child's life;

11. delivered more than one baby during most recent pregnancy (twins, triplets, etc.).

12. exclusively breastfeeding

Exclusion criteria for non-addicted mothers:

Potential control subjects will be ineligible if they have:

1. positive drug toxicology screen at any point in the study;

2. drug abuse or dependence based on MINI in the past year or lifetime;

3. use of tobacco products in the past 2 years;

4. current hazardous alcohol use as ascertained by AUDIT score > 8;

5. present or past history of ambulatory detoxification;

6. severe psychiatric symptoms requiring inpatient psychiatric hospitalization for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the past 30 days;

7. past or present diagnosis of schizophrenia or other psychotic disorders;

8. metal implants or other contraindications for MRI scanning;

9. current pregnancy or plans to become pregnant during the course of the study;

10. infants with birth weight less than 3 lb. 5 oz.;

11. infants who have significant vision, hearing or motor problems that cannot be corrected (such as cerebral palsy);

12. mothers who have significant vision or hearing problems that cannot be corrected;

13. out-of-home placement of infant for the past month or more than 50% of child's life; and

14. delivered more than one baby during most recent pregnancy (twins, triplets, etc.).

15. exclusively breastfeeding