An observational study in Pre-natal Cocaine Exposure and Risk-Taking, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by Yale University · Observational
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.
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.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 78 is below the median of 120 across 17 observational studies indexed under Risk-Taking.
Browse Risk-Taking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Emerging adult individuals who were exposed to cocaine in-utero
Other: fMRI
Emerging adult individuals who were not exposed to cocaine in-utero
Other: fMRI
Observation of neural markers of reward processing
Also known as: EEG
Change in Risk-taking behavior:Drug and alcohol use
Teen Addiction Severity Index (Interview)
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in Risk-taking behavior:gambling behaviors
Massachusetts gambling screen (MAGS)
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in affect over time
Positive and Negative Affect Scales (PANAS)
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in alexithymia over time
Toronto Alexithymia Scale (TAS-20)
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in experience of reward
Chapman Social and Physical Anhedonia Questionnaires
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in emotion regulation strategies
Emotion regulation questionaire (ERQ)
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Sep 2020, 35 months.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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