Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

NCT ID: NCT03268759

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2020-09-14

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.

Detailed Description

This cohort will be drawn from a pre-existing cohort of individuals recruited as part of an already existing study, and who have been followed since birth. Reward processing will be measured in two temporally close testing sessions involving two methodologies, electrophysiology and fMRI. Information will also be collected pertaining to experimental and problematic drug use, as well as information about mood, at the recording sessions. Drug use and mood information will then be collected once again in quarterly follow-up sessions for one year. The goal is to examine if PCE status and reward processing are risk factors for problematic drug abuse and risky behaviors in emerging adulthood, and if these factors interact to increase such risk.

Conditions

Pre-natal Cocaine Exposure; Risk-Taking

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PCE

Emerging adult individuals who were exposed to cocaine in-utero

fMRI

Intervention Type: OTHER

Observation of neural markers of reward processing

NCE

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

fMRI

Intervention Type: OTHER

Observation of neural markers of reward processing

Interventions

fMRI

Observation of neural markers of reward processing

Intervention Type: OTHER

Other Intervention Names

EEG

Eligibility Criteria

Inclusion Criteria

1. Ability to provide written informed consent and to comply with all study procedures.

2. Healthy emerging adults between 18-20 years of age (the age of the currently followed sample at the time of the proposed start date).

Exclusion Criteria

• 1. 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.

3. Evidence of stroke or space occupying lesions observed on conventional, clinical MR images.

4. 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.

6. 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.

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Child Study Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1K01DA042937

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0203014534

Identifier Type: -

Identifier Source: org_study_id