- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268759
Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Child Study Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PCE
Emerging adult individuals who were exposed to cocaine in-utero
|
Observation of neural markers of reward processing
Other Names:
|
NCE
Emerging adult individuals who were not exposed to cocaine in-utero
|
Observation of neural markers of reward processing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4x per year for one year (Baseline, 4 months, 8 months, 12 months)
|
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)
|
4x per year for one year (Baseline, 4 months, 8 months, 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
Toronto Alexithymia Scale (TAS-20)
|
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)
|
Chapman Social and Physical Anhedonia Questionnaires
|
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)
|
Emotion regulation questionaire (ERQ)
|
4x per year for one year (Baseline, 4 months, 8 months, 12 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0203014534
- 1K01DA042937 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Risk-Taking
-
Centre Hospitalier Universitaire de BesanconPlateforme NeuraxessRecruitingEmotional Regulation | Risk-TakingFrance
-
University of California, IrvineRecruitingAdolescent Behavior | Risk-TakingUnited States
-
University of BirminghamCompletedRisk-Taking | AttitudeUnited Kingdom
-
Abt AssociatesDepartment of Health and Human Services; Decision Information Resources (DIR)CompletedTeen Pregnancy | Sexual Risk-taking Behaviors
-
LI ChengNot yet recruitingRisk-Taking | Chronic Stress
-
Barcelona Institute for Global HealthRecercaixa; Centre de Recerca per a l'Educació Científica i Matemàtica (CRECIM) and other collaboratorsCompletedRisk Behavior | Attention Impaired | Risk-Taking | Social Preferences | Decision Making | AttentionSpain
-
Malahat AmaniCompletedRisk-Taking | Self-Control | Humor as TopicIran, Islamic Republic of
-
Parc de Salut MarGermans Trias i Pujol HospitalCompletedRisk Behavior | Epilepsy | Risk-Taking | Epilepsy; Seizure
-
University of California, San FranciscoNorth Carolina State UniversityNot yet recruitingAlcohol Drinking | Cancer | Self Efficacy | Adolescent Behavior | Risk-TakingUnited States
-
Olivia ChoyRWTH Aachen UniversityCompletedAggression | Risk-Taking | Antisocial BehaviorGermany
Clinical Trials on fMRI
-
Weill Medical College of Cornell UniversityMemorial Sloan Kettering Cancer CenterWithdrawnBrain TumorsUnited States
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedMagnetic Resonance Imaging | Neuronal ActivityFrance
-
Centre Hospitalier Universitaire de Saint EtienneUniversity Hospital of Saint-EtienneCompleted
-
Brighton & Sussex Medical SchoolRecruitingDepressionUnited Kingdom
-
Van Boven, Robert W., M.D.Massachusetts Institute of Technology; The Geneva FoundationUnknownTraumatic Brain Injury | Post Traumatic Stress DisorderUnited States
-
Hospices Civils de LyonUniversity of KonstanzCompleted
-
Boston VA Research Institute, Inc.Mclean Hospital; Cambridge Health Alliance; Northeastern UniversityRecruitingSchizophrenia | Treatment-resistant Schizophrenia | Auditory HallucinationUnited States