Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT02979093
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02979093
Study Brief:
Protocol Section:
NCT02979093