Screening Protocol for the Evaluation of Research Participants
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 18, 2009 |
| Last Updated Date | June 18, 2010 |
| Start Date ICMJE | May 2006 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01036217 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Screening Protocol for the Evaluation of Research Participants |
| Official Title ICMJE | Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies |
| Brief Summary | Background: - The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to develop a pool of potential participants for research studies. Because some of the data collected during screening are used later for research, the screening itself is considered a study. An applicant to any NIDA study is considered a participant in NIDA screening. Objectives: - To identify, recruit, and screen participants for NIDA research protocols. Eligibility: - Individuals 18 years of age and older who are able to provide informed consent. Design:
|
| Detailed Description | 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 NIDA IRP 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE |
|
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 55000 |
| Completion Date | June 2010 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE |
EXCLUSION CRITERIA: 1. Inability to provide valid informed consent. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01036217 |
| Other Study ID Numbers ICMJE | 999906412, 06-DA-N412 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|