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Health Outcomes by Neighborhood - Baltimore

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01571752
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

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.

Condition or disease
Stigma Activity Space Social Networks HIV Status Drug Abuse/Dependence

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 1651 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Health Outcomes by Neighborhood - HON Study Baltimore
Actual Study Start Date : July 17, 2012

Group/Cohort
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



Primary Outcome Measures :
  1. 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) [ Time Frame: 12 months ]
    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)

  2. To provide neighborhood-matched control groups of non-drug-using individuals, Unclassified/former drug users, and current opioid/stimulant drug users not seeking treatment [ Time Frame: 12 months ]
    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)

  3. 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 [ Time Frame: 12 months ]
    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)

  4. To assess, longitudinally, mediators of 12-month changes in drug-misuse status in the same three groups [ Time Frame: 12 months ]
    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)

  5. To assess the accuracy of stress detection in the lab and the field by the Health Tag [ Time Frame: 12 months ]
    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)

  6. 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 [ Time Frame: 12 months ]
    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)


Secondary Outcome Measures :
  1. Random-signal-triggered recordings [ Time Frame: Daily ]
    Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors

  2. One-day laboratory session [ Time Frame: Once ]
    Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors

  3. Clinic Compliance Visit [ Time Frame: Weekly ]
    Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors

  4. Brief end of day recording [ Time Frame: Daily ]
    Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors

  5. 30-day field study [ Time Frame: post-30 day ]
    Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

-Inability to provide informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571752


Locations
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United States, Maryland
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lorenzo Leggio, M.D. National Institute on Drug Abuse (NIDA)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01571752    
Other Study ID Numbers: 999912472
12-DA-N472
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: September 23, 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Drug Abuse
Ecological Momentary Assessment (EMA)
Environment
Genetic
Longitudinal
Natural History
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders