Health Outcomes by Neighborhood - Baltimore

NCT01571752 | Completed

• 2 other identifiers: 99991247212-DA-N472
• Study Type: observational
• Target: 1,651
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Researchers have been studying patterns of mood and drug use in specific neighborhoods. This study will look at environmental factors that may affect drug use, addiction, and treatment seeking in Baltimore neighborhoods. The results could inform prevention efforts, enhance treatment interventions, and improve substance use outcomes. Objectives: \- To better understand why some people start to use drugs, why some people who use drugs become addicted, and why some people who become addicted enter treatment. Eligibility: \- Individuals at least 18 years of age who are living in the neighborhoods participating in the study. Design:

• Participants will be screened with a physical exam and medical history. They will be separated into one of four groups: (1) people who do not use drugs, (2) people who have used drugs in the past, (3) people who are using drugs and want treatment, and (4) people who are using drugs and do not want treatment.
• This study will include two outpatient visits about 12 months apart. Each visit will last about 5 hours. Each study visit may be done in 1 day or in 2 days.
• At each study visit, participants will provide blood, breath, urine, and saliva samples. They will also have a heart function test and body measurements. They will complete questionnaires about personal and family history.
• There will be monthly follow-up phone calls between the two visits.

Conditions

HIV Status; Drug Abuse/Dependence; Stigma; Activity Space; Social Networks

Keywords

Drug Abuse; Ecological Momentary Assessment (EMA); Environment; Genetic; Longitudinal; Natural History

Outcome Measures

Primary Outcomes (6)

• We will examine environmental factors that may impact initiation, addiction, and treatment seeking among the greater population at large (non-drug-users, current opioid/stimulant users, and current marijuana users)

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

• To provide neighborhood-matched control groups of non-drug-using individuals, Unclassified/former drug users, and current opioid/stimulant drug users not seeking treatment

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

• To explore the possible role of genetics and its interplay with environment in regards to drug use initiation, addiction, and treatment seeking among the study groups

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

• To assess, longitudinally, mediators of 12-month changes in drug-misuse status in the same three groups

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

• To assess the accuracy of stress detection in the lab and the field by the Health Tag

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

• To assess EMA reports of drug use and psychosocial stress as well as real-time environmental risk exposure in a non-treatment seeking and/or nondrug using population

  The primary outcome measures will be lifetime substance-misuse history (cross-sectional component) and changes in drug-use status across the 12 months between visits (longitudinal component)

  12 months

Secondary Outcomes (5)

• Random-signal-triggered recordings

  Daily

• One-day laboratory session

  Once

• Clinic Compliance Visit

  Weekly

• Brief end of day recording

  Daily

• 30-day field study

  post-30 day

Study Arms (11)

CMU

Current marijuana users

Cohort 1 - NIH Negative

HIV negative adults

Cohort 1- HIV Positive

HIV positive adults

Cohort 2 Seeds-Wave 0

HIV positive adults

Cohort 2 Wave 1

HIV negative adults or HIV positive adults

Cohort 2 Wave 2

HIV negative adults or HIV positive adults

COSU

Current opioid/stimulant users

COSU-NTS

Non-treatment seekers

COSU-TS

Treatment seekers

NDU

Non-drug-users

Unclassified

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 650 participants in Phase B of the study for a total enrollment (Phase A + Phase B + Phase C) of 3000 participants. Target enrollment will include 25% women and 70% minorities (mostly African-American).

You may qualify if:

• The enrollment target in Phase B is 650 community-dwelling individuals (at least 325 of whom we anticipate will provide 12-month Visit #2 data in our 3 main study groups). Enrollment for Phase A + Phase B + Phase C =3000.
• Age at least 18 years. Rationale: Children under 18 will not be included because many of the measures to be administered in this study are not validated for use with children. Furthermore, the research question under investigation is the drug trajectories of adults, over the age of 18. However, there is no intervention in this study that is contraindicated for older adults, and given that addiction in the elderly is understudied, it is important to include elderly individuals.
• Residence in Baltimore city or one of the surrounding counties. Rationale: Our current geographic mapping technology currently only includes these areas.

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Panlilio LV, Preston KL, Bertz JW, Moran LM, Tyburski M, Hertzel SK, Husami S, Adan F, Epstein DH, Phillips KA. Objective Neighborhood-Level Disorder Versus Subjective Safety as Predictors of HIV Transmission Risk and Momentary Well-Being. AIDS Behav. 2024 Oct;28(10):3326-3337. doi: 10.1007/s10461-024-04413-z. Epub 2024 Jul 4.

  PMID: 38965184 DERIVED

• Moran LM, Panlilio LV, Hertzel SK, Bertz JW, Tyburski M, Etter JR, Epstein DH, Preston KL, Phillips KA. Health Outcomes by Neighborhood (HON): Effects of Neighborhood, Social Instability, and Health Factors on 12-Month Trajectories of Substance-Use Disorder Symptoms. Subst Use Misuse. 2023;58(12):1460-1472. doi: 10.1080/10826084.2023.2223258. Epub 2023 Jun 28.

  PMID: 37380598 DERIVED

• Stull SW, Panlilio LV, Moran LM, Schroeder JR, Bertz JW, Epstein DH, Preston KL, Phillips KA. The chippers, the quitters, and the highly symptomatic: A 12-month longitudinal study of DSM-5 opioid- and cocaine-use problems in a community sample. Addict Behav. 2019 Sep;96:183-191. doi: 10.1016/j.addbeh.2019.04.030. Epub 2019 Apr 29.

  PMID: 31108264 DERIVED

MeSH Terms

Conditions

Social Stigma; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lorenzo Leggio, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 5, 2012
• Study Start: July 17, 2012
• Last Updated: April 29, 2026

Record last verified: 2025-12-04

Locations

US (1)