Screening Protocol for the Evaluation of Potential Research Subjects
|First Received Date ICMJE||December 18, 2009|
|Last Updated Date||October 16, 2014|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To identify, recruit and screen participants for NIDA IRP protocols.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01036971 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To be able to have the screening data obtained be shared across all IRB approved, NIDA-IRP protocols.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Screening Protocol for the Evaluation of Potential Research Subjects|
|Official Title ICMJE||Screening Protocol for the Evaluation of Potential Research Subjects|
- The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen adolescents and adults who may be eligible for future research studies.
- To identify, recruit, and screen participants for NIDA neuroimaging research protocols.
- Individuals 13 years of age and older who are able to provide informed consent.
This protocol describes the screening process used by the National Institute on Drug Abuse (NIDA IRP) to assess potential research participants eligibility for entering protocols of the NIDA/IRP. Through its clinical research protocols, the NIDA IRP attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. In support of the IRP s work, the scientific goal of this screening protocol is to assess potential research participants eligibility for the IRPs research studies. Screening will include medical and psychological tests and procedures. The data collected during screening are a unique and valuable source of information that aids in NIDA s mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting NIDA about research participation and to analyze data so obtained, such as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases. The population screened includes male and female adolescents ages 13-17 for NIDA only and adults age greater than or equal to 18 for both IRPs. Screening procedures include standard medical and psychological tests and procedures are minimal risk. There is no direct benefit to subjects. Participants are paid for undergoing the screening process.
Most genetics data will be collected under the aegis of protocol 10-DA-N457 and will be compared with data collected under this study. Some studies require genotyping to be done as part of screening. Those DNA samples will be stored so that if active or returning participants are screened for future studies requiring genotyping during screening an additional blood draw won t be required.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||5000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||13 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01036971|
|Other Study ID Numbers ICMJE||999906415, 06-DA-N415|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP