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OpenTrials
Completed

NCT Number: NCT03268759

Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

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.

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Key information

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child Study Center

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent and to comply with all study procedures.
  • 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.
  • Evidence of stroke or space occupying lesions observed on conventional, clinical MR images.
  • 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.
  • 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.
  • 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.

Treatment and study plan

fMRI

Other

Observation of neural markers of reward processing

Other names: EEG

Primary outcomes

  1. Change in Risk-taking behavior:Drug and alcohol use

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Teen Addiction Severity Index (Interview)

  2. Change in Risk-taking behavior:gambling behaviors

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Massachusetts gambling screen (MAGS)

Secondary outcomes

  1. Change in affect over time

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Positive and Negative Affect Scales (PANAS)

  2. Change in alexithymia over time

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Toronto Alexithymia Scale (TAS-20)

  3. Change in experience of reward

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Chapman Social and Physical Anhedonia Questionnaires

  4. Change in emotion regulation strategies

    Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)

    Emotion regulation questionaire (ERQ)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2017
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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