Screening Protocol for the Evaluation of Potential Research Subjects

Background:

- 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.

Objectives:

- To identify, recruit, and screen participants for NIDA neuroimaging research protocols.

Eligibility:

- Individuals 18 years of age and older who are able to provide informed consent.

Design:

• Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview. Adolescents who are eligible for further screening must bring a parent or guardian with them to the in-person interview.
• The in-person interview may require up to five visits to the NIDA clinical center. The in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
• During the screening process, participants will be explicitly asked for permission to recontact them after the 1-year duration of the screening protocol. For minors, both the adolescent and the parent/guardian must agree to future contact.
• No clinical care will be provided under this protocol.

Study Overview

• Status: Recruiting
• Conditions: Addiction

Detailed Description

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 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 IRP's 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 IRP's mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting the IRP about research participation and to analyze data so obtained, such as that on the prevalence and co-occurrence of pregnancy, HIV/AIDS, viral hepatitis, and related diseases. The population screened includes male and female adults age >= 18. 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 other protocols 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 will not be required.

• Study Type: Observational
• Enrollment (Estimated): 7500

Contacts and Locations

• Study Contact: Name: Lorenzo Leggio, M.D.; Phone Number: (240) 478-1503; Email: lorenzo.leggio@nih.gov
• Study Contact Backup: Name: NIDA IRP Screening Team; Phone Number: (800) 535-8254; Email: researchstudies@nida.nih.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • National Institute on Drug Abuse, Biomedical Research Center (BRC)
      • Contact: Shannon Pfistner; Phone Number: 800-535-8254; Email: pfistners@nida.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Screening protocol for all NIDA clinical studies

Description

• INCLUSION CRITERIA:

  1. Males and females ages 18 or older.

EXCLUSION CRITERIA:

1. Phone screen: Subjects who are unable to understand or adequately answer questions posed in the phone screen.
2. Phone screen and in-person screen: Subjects unable to provide informed consent.
3. Pregnant women

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; potential research subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening for NIDA studies	Screening for NIDA studies	baseline

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lorenzo Leggio, M.D., National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2006
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimated): December 21, 2009

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Physical Examination; Medical Information; Assessment; Blood Work; Screening
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: 999906415; 06-DA-N415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: .No plan depicted in protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No