Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01571752 |
| Other study ID # |
999912472 |
| Secondary ID |
12-DA-N472 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 17, 2012 |
Study information
| Verified date |
February 29, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
