Screening Protocol for the Evaluation of Potential Research Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01036971|
Recruitment Status : Recruiting
First Posted : December 21, 2009
Last Update Posted : February 19, 2018
|First Submitted Date||December 18, 2009|
|First Posted Date||December 21, 2009|
|Last Update Posted Date||February 19, 2018|
|Start Date||May 16, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||To identify, recruit and screen participants for NIDA IRP protocols.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01036971 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||To be able to have the screening data obtained be shared across all IRB approved, NIDA-IRP protocols.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Screening Protocol for the Evaluation of Potential Research Subjects|
|Official Title||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 either the NIDA/IRP. Through its clinical research protocols, the IRPs attempt 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 IRPs 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 the IRPs missions. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting the IRPs 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 > 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 Design||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||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.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999906415
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )|
|Study Sponsor||National Institute on Drug Abuse (NIDA)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 30, 2017|