Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

NCT03268759 | Completed

• 2 other identifiers: 02030145341K01DA042937
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Reward processing will be examined in prenatally exposed emerging adults in a longitudinal design. Participants will be followed for one year to see if neural markers of reward processing prospectively predict risk-taking behavior.

Conditions

Pre-natal Cocaine Exposure; Risk-Taking

Keywords

substance abuse

Outcome Measures

Primary Outcomes (2)

• Change in Risk-taking behavior:Drug and alcohol use

  Teen Addiction Severity Index (Interview)

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

• Change in Risk-taking behavior:gambling behaviors

  Massachusetts gambling screen (MAGS)

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

Secondary Outcomes (4)

• Change in affect over time

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

• Change in alexithymia over time

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

• Change in experience of reward

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

• Change in emotion regulation strategies

  4x per year for one year (Baseline, 4 months, 8 months, 12 months)

Study Arms (2)

PCE

Emerging adult individuals who were exposed to cocaine in-utero

Other: fMRI

NCE

Emerging adult individuals who were not exposed to cocaine in-utero

Other: fMRI

Interventions

fMRI OTHER

Observation of neural markers of reward processing

Also known as: EEG

NCE; PCE

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Emerging adults in this study will be drawn from a sample of 359 individuals who have been participating in a longitudinal study of the effects of PCE on physical, social, cognitive and emotional development. Children and their mothers who were exposed to drugs other than cocaine were also enrolled, as were non-drug exposed controls. Prenatal drug exposure status was ascertained at time of recruitment via a detailed interview that covered lifetime substance use and use in the past 30 days, as well as a urine screening of mother and infant and meconium toxicology. The sample from which participants will be recruited consists of 81% African American, 6.5% Hispanic and 12.5% Caucasian children, all of who come from the greater New Haven area. The sample was recruited at birth over a 5-year period.

You may qualify if:

• Ability to provide written informed consent and to comply with all study procedures.
• Healthy emerging adults between 18-20 years of age (the age of the currently followed sample at the time of the proposed start date).

You may not qualify if:

• \. A serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain. 2. A medical condition that requires treatment with a medication with psychotropic effects.
• \. Evidence of stroke or space occupying lesions observed on conventional, clinical MR images.
• \. Any contraindications to MRI scanning (i.e., metal implants, pacemakers, etc.) 5. History of loss of consciousness (LOC) for longer than 30 minutes or LOC with any neurological sequelae.
• \. DSM-5 criteria for intellectual disability. 7. Current or a history of active neurological or psychiatric disorders, such as psychosis, bipolar illness, major depression, organic brain disease, dementia or DSM-V Axis I Psychiatric Disorder, including current alcohol or substance disorders. Participants will not be excluded for substance or alcohol use, only the presence of substance disorders.
• \. Current pregnancy. Female participants will be excluded if they report being currently pregnant or present positive for pregnancy after being given a urine test at the time of recruitment or scanning. If they become pregnant during the one-year follow-up duration of the study after the MRI scan is completed, they will remain in the study for the quarterly follow-ups and be referred to pre-natal care if they have not begun such care already.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Risk-Taking; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavior; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 31, 2017
• Study Start: September 15, 2017
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)