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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03268759
Other study ID # 0203014534
Secondary ID 1K01DA042937
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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