StigmaNCT01571752
Health Outcomes by Neighborhood - Baltimore
An observational study of Stigma and Activity Space, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stigma, Activity Space, Social Networks
- How many people
- 1,651 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- -Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Official title: Health Outcomes by Neighborhood - HON Study Baltimore
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.
Read more
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.
Read the detailed description
Phase B
Background. The reasons for initiation and continuation of use of illicit substances are multifactorial; however, some individuals appear resistant to both. One set of determinants lies in the environment. In ongoing studies, we are examining environmental concomitants of behavior in individuals in drug treatment. In this study, we will examine environmental factors that may impact initiation, addiction, and treatment seeking among the greater population at large (nondrug-users, current opioid/stimulant users, and current marijuana users).
Scientific goals. (1) To assess, cross-sectionally at baseline, differences in stress, social stability, and mental and physical health among three main neighborhood-matched groups of current opioid/stimulant users, current marijuana users, and nondrug users; (2) to assess, longitudinally, mediators of 12-month changes in drug-misuse status in the same three groups; (3) to provide neighborhood-matched control groups of non-drug-using individuals, Unclassified/former drug users, and current opioid/stimulant drug users not seeking treatment for our ongoing environmental studies of individuals in drug treatment; (4) 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, (5) 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 and compare to our ongoing environmental studies of individuals in drug treatment, (6) to assess the accuracy of stress detection in the lab and the field by the Health Tag.
Participant 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).
Experimental design and methods. This is a three-group observational study with a crosssectional component and a longitudinal component: each participant will be assessed in two visits spaced approximately 12 months apart. For participants enrolled in Phase B after January 26, 2021, the interval between the two visits may be shorter than 12 months. The three main groups will be: (1) non-drug-users (NDUs), (2) current opioid/stimulant users [(COSUs) comprised of two subgroups: treatment seeking (COSU-TS) and non treatment seeking (COSU-NTS)], and current marijuana users (CMUs). All groups will be roughly matched for socioeconomic status and neighborhoods of residence. Each participant will attend a 3-5-hour initial study visit and a 3-5-hour 12 month visit #2. The study visits will include a questionnaire component and a biologicalsample component. Questionnaires will cover substance use, stress, social stability (including healthcare access/utilization, and neighborhood environment), physical and mental health (including quality of life, HIV, and trauma). The biological component will consist of samples of urine (for drugs of abuse and cotinine), breath (for alcohol and carbon monoxide). Blood for genetics will be obtained at Visit 1 or Visit 2. 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 will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors. Individuals who choose not to return for a 12-month Visit #2 will be asked to complete a 45-minute telephone visit #2. For participants enrolled in Phase B after January 26, 2021, all participants will be asked to complete their visit #2 by telephone only. In the HON EMA/GMA secondary study participants will carry a smartphone for up to 4 weeks after completing Visit 1. Event-triggered entries will be initiated by participants (1) each time that they use a drug (COSU) or marijuana and/or alcohol (NDU, CMU, and Unclassified) and (2) each time they feel overwhelmed, anxious, or stressed more than usual. Participants will also make 5 random-signal-triggered recordings per day and one brief end of day recording. During this study participants will also complete compliance visits once per week. In the Health Tag secondary study, participants will undergo a one-day laboratory session followed by a 30-day field study. Benefits to participants and/or society. There are no benefits to participants. The knowledge gained may benefit society by providing data on the health outcomes of drug-using and non-drugusing individuals and the natural history of drug use by neighborhood.
Risks to participants. This is a minimal-risk study, consisting of standard physical and questionnaire-based assessments.
- Conditions
- Stigma, Activity Space, Social Networks, HIV Status, Drug Abuse/Dependence
- Keywords
- Drug Abuse, Ecological Momentary Assessment (EMA), Environment, Genetic, Longitudinal, Natural History
- Medical subject headings
- Social Stigma, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Secondary outcomes (5)
Random-signal-triggered recordings
Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors
Measured: Daily
One-day laboratory session
Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors
Measured: Once
Clinic Compliance Visit
Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors
Measured: Weekly
Brief end of day recording
Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors
Measured: Daily
30-day field study
Secondary outcome measures will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors
Measured: post-30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study start17 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StigmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571752
- Sponsor's protocol ID
- 999912472
- Other IDs
- 12-DA-N472
- Status last verified
- 4 Nov 2026
- First submitted
- 4 Apr 2012
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38965184Moran 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.
PubMed 37380598Stull 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.
PubMed 31108264
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes by Neighborhood - HON Study Baltimore
- ClinicalTrials.gov ID
- NCT01571752
- Acronym / sponsor ID
- 999912472
- Conditions
- Stigma, Activity Space, Social Networks, HIV Status, Drug Abuse/Dependence
- Keywords
- Drug Abuse, Ecological Momentary Assessment (EMA), Environment, Genetic, Longitudinal, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,651 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 17 Jul 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase B
Background. The reasons for initiation and continuation of use of illicit substances are multifactorial; however, some individuals appear resistant to both. One set of determinants lies in the environment. In ongoing studies, we are examining environmental concomitants of behavior in individuals in drug treatment. In this study, we will examine environmental factors that may impact initiation, addiction, and treatment seeking among the greater population at large (nondrug-users, current opioid/stimulant users, and current marijuana users).
Scientific goals. (1) To assess, cross-sectionally at baseline, differences in stress, social stability, and mental and physical health among three main neighborhood-matched groups of current opioid/stimulant users, current marijuana users, and nondrug users; (2) to assess, longitudinally, mediators of 12-month changes in drug-misuse status in the same three groups; (3) to provide neighborhood-matched control groups of non-drug-using individuals, Unclassified/former drug users, and current opioid/stimulant drug users not seeking treatment for our ongoing environmental studies of individuals in drug treatment; (4) 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, (5) 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 and compare to our ongoing environmental studies of individuals in drug treatment, (6) to assess the accuracy of stress detection in the lab and the field by the Health Tag.
Participant 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).
Experimental design and methods. This is a three-group observational study with a crosssectional component and a longitudinal component: each participant will be assessed in two visits spaced approximately 12 months apart. For participants enrolled in Phase B after January 26, 2021, the interval between the two visits may be shorter than 12 months. The three main groups will be: (1) non-drug-users (NDUs), (2) current opioid/stimulant users [(COSUs) comprised of two subgroups: treatment seeking (COSU-TS) and non treatment seeking (COSU-NTS)], and current marijuana users (CMUs). All groups will be roughly matched for socioeconomic status and neighborhoods of residence. Each participant will attend a 3-5-hour initial study visit and a 3-5-hour 12 month visit #2. The study visits will include a questionnaire component and a biologicalsample component. Questionnaires will cover substance use, stress, social stability (including healthcare access/utilization, and neighborhood environment), physical and mental health (including quality of life, HIV, and trauma). The biological component will consist of samples of urine (for drugs of abuse and cotinine), breath (for alcohol and carbon monoxide). Blood for genetics will be obtained at Visit 1 or Visit 2. 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 will include: biological assessments of drug use; medical, psychiatric, social determinants of health; and impulsivity and decision-making factors. Individuals who choose not to return for a 12-month Visit #2 will be asked to complete a 45-minute telephone visit #2. For participants enrolled in Phase B after January 26, 2021, all participants will be asked to complete their visit #2 by telephone only. In the HON EMA/GMA secondary study participants will carry a smartphone for up to 4 weeks after completing Visit 1. Event-triggered entries will be initiated by participants (1) each time that they use a drug (COSU) or marijuana and/or alcohol (NDU, CMU, and Unclassified) and (2) each time they feel overwhelmed, anxious, or stressed more than usual. Participants will also make 5 random-signal-triggered recordings per day and one brief end of day recording. During this study participants will also complete compliance visits once per week. In the Health Tag secondary study, participants will undergo a one-day laboratory session followed by a 30-day field study. Benefits to participants and/or society. There are no benefits to participants. The knowledge gained may benefit society by providing data on the health outcomes of drug-using and non-drugusing individuals and the natural history of drug use by neighborhood.
Risks to participants. This is a minimal-risk study, consisting of standard physical and questionnaire-based assessments.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
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)
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)
5 secondary outcomes
Random-signal-triggered recordings
Time frame: Daily
One-day laboratory session
Time frame: Once
Clinic Compliance Visit
Time frame: Weekly
Brief end of day recording
Time frame: Daily
30-day field study
Time frame: post-30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 38965184Panlilio 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.
- Derived from this study: PubMed 37380598Moran 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.
- Derived from this study: PubMed 31108264Stull 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Leggio, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stigma and Activity Space, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571752, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.