Pre-natal Cocaine ExposureNCT03268759
Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults
An observational study of Pre-natal Cocaine Exposure and Risk-Taking, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-natal Cocaine Exposure, Risk-Taking
- What is being tested?
- fMRI
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pre-natal Cocaine Exposure, Risk-Taking
- Being tested
- fMRI
- Keywords
- substance abuse
- Medical subject headings
- Risk-Taking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Also called EEG
Observation of neural markers of reward processing
| Study group | Role | What they receive |
|---|---|---|
| PCE | Emerging adult individuals who were exposed to cocaine in-utero Receives: Other: fMRI | |
| NCE | Emerging adult individuals who were not exposed to cocaine in-utero Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Risk-taking behavior:Drug and alcohol use
Teen Addiction Severity Index (Interview)
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in Risk-taking behavior:gambling behaviors
Massachusetts gambling screen (MAGS)
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Secondary outcomes (4)
Change in affect over time
Positive and Negative Affect Scales (PANAS)
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in alexithymia over time
Toronto Alexithymia Scale (TAS-20)
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in experience of reward
Chapman Social and Physical Anhedonia Questionnaires
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in emotion regulation strategies
Emotion regulation questionaire (ERQ)
Measured: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start15 Sep 2017
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-natal Cocaine ExposureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268759
- Sponsor's protocol ID
- 0203014534
- Other IDs
- 1K01DA042937
- Status last verified
- May 2021
- First submitted
- 25 Aug 2017
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT03268759
- Acronym / sponsor ID
- 0203014534
- Conditions
- Pre-natal Cocaine Exposure, Risk-Taking
- Keywords
- substance abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCE | – | Other: fMRIEmerging adult individuals who were exposed to cocaine in-utero |
| NCE | – | Other: fMRIEmerging adult individuals who were not exposed to cocaine in-utero |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIAlso: EEGObservation of neural markers of reward processing | Other | NCE, PCE |
Primary outcome
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)
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)
4 secondary outcomes
Change in affect over time
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in alexithymia over time
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in experience of reward
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Change in emotion regulation strategies
Time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-natal Cocaine Exposure and Risk-Taking, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Risk-taking behavior:Drug and alcohol use (time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.