Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

Completed

• Conditions: Pre-natal Cocaine Exposure; Risk-Taking
• Interventions: Other: fMRI

• Registration Number: NCT03268759
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Start: 2017-09-15
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-01
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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).

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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.

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

  3. 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.

  4. 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.

  5. 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NCE	fMRI	Emerging adult individuals who were not exposed to cocaine in-utero
PCE	fMRI	Emerging adult individuals who were exposed to cocaine in-utero

Primary Outcome Measures

Name	Time	Method
Change in Risk-taking behavior:gambling behaviors	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Massachusetts gambling screen (MAGS)
Change in Risk-taking behavior:Drug and alcohol use	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Teen Addiction Severity Index (Interview)

Secondary Outcome Measures

Name	Time	Method
Change in affect over time	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Positive and Negative Affect Scales (PANAS)
Change in alexithymia over time	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Toronto Alexithymia Scale (TAS-20)
Change in emotion regulation strategies	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Emotion regulation questionaire (ERQ)
Change in experience of reward	4x per year for one year (Baseline, 4 months, 8 months, 12 months)	Chapman Social and Physical Anhedonia Questionnaires

Trial Locations

Locations (1)

Child Study Center; 🇺🇸 New Haven, Connecticut, United States