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Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults

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ClinicalTrials.gov Identifier: NCT03268759
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pre-natal Cocaine Exposure Risk-Taking Other: fMRI

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 Design

Study Type : Observational
Estimated Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 14, 2020
Estimated Study Completion Date : September 14, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
PCE
Emerging adult individuals who were exposed to cocaine in-utero
Other: fMRI
Observation of neural markers of reward processing
Other Name: EEG
NCE
Emerging adult individuals who were not exposed to cocaine in-utero
Other: fMRI
Observation of neural markers of reward processing
Other Name: EEG


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268759


Locations
United States, Connecticut
Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03268759     History of Changes
Other Study ID Numbers: 0203014534
1K01DA042937 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
substance abuse