Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

Risk-Taking Clinical Trial

Official title:

Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268759
• Other study ID #: 0203014534
• Secondary ID: 1K01DA042937
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: September 14, 2020

Study information

• Verified date: May 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-natal Cocaine Exposure
• Risk-Taking

Intervention

Other:
• fMRI
Observation of neural markers of reward processing

Locations

Country	Name	City	State
United States	Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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