Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population

NCT00787423 | Completed

• 2 other identifiers: 99990902009-DA-N020
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Researchers are interested in developing more accurate methods to assess environmental influences on psychological stress and drug use. One key to a more accurate assessment of environmental influences is minimizing the delay between exposure and reporting. Portable devices such as personal digital assistants (PDAs) and global positioning system (GPS) units may be able to provide a more real-time image of these factors. Objectives: \- To assess the use of PDAs to measure stress and drug use, and GPS units to assess the effects of neighborhood environment in an outpatient treatment population. Eligibility:

• Individuals from 18 to 75 years of age who are current heroin users seeking treatment for addiction and who spend most of their time in Baltimore city.
• Participants must be able to visit the research and treatment center at least three times per week for regular tests. Design:
• Participants will be in the study for approximately 28 weeks (7 months).
• A series of three laboratory session examining responsiveness to standardized stressors will occur both early in treatment and will be repeated late in treatment.
• Participants will undergo 18 weeks of daily methadone maintenance. Urine samples will be collected three times weekly.
• To track drug use, stress, and geographical location (a measure of environmental risk), each participant will carry a PDA and a GPS unit for 16 of the 18 weeks. Participants will make entries (1) each time that they use a drug and (2) each time they feel overwhelmed, anxious, or stressed more than usual. Participants will also make three random-signal-triggered recordings per day and one brief (end of day) recording.
• Retrospective self-report questionnaires on drug use and stress will be given regularly.
• After 18 weeks of methadone maintenance, participants will discontinue carrying the PDA and GPS unit and will have the choice of transferring to a community clinic or undergoing a 10-week taper from methadone at the research clinic. Participants who stay for the taper will continue to provide urine samples, but only once a week.

Conditions

Stress; Drug Abuse

Keywords

Field Tools; Stress; Ecological Monetary Assessment (EMA); Global Positioning Units; Natural History; Psychosocial Stress

Outcome Measures

Primary Outcomes (2)

• Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index

  Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index

  real-time assessment

• EMA reports of drug use and psychosocial stress

  EMA reports of drug use and psychosocial stress

  real-time assessment

Secondary Outcomes (13)

• To determine the feasibility and acceptability of interactive mHIVRR software programs to deliver counseling and HIV education, and to determine whether they reduce HIV-related risk via increased HIV/STD knowledge

  Ongoing

• To evaluate sleep quality in relationship to drug use and stress exposure

  Ongoing

• Incorporate genetic characteristics as predictors of EMA and GMA data and other behavioral measures

  Ongoing

• To determine if the HPA axis is normal after at least 3 months of opioid agonist treatment

  Ongoing

• Determine the feasibility of using a more up-to-date EMA interface and device

  Ongoing

Study Arms (1)

COHORT 1

Individuals from 18 to 75 years of age who are current heroin users seeking treatment for addiction and who spend most of their time in Baltimore city.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Opioid-dependent outpatient adults (up to 500 enrolled; up to 400 completers). Target enrollment will include 40% women and 60% minorities (mostly African-American).@@@@@@

You may qualify if:

• Daily Treatment and OBOT arm-
• Age between 18 and 75
• Physical dependence on opioids (by positive urine and/or frank opioid withdrawal)
• Baltimore City or Baltimore, Harford, Howard, or Anne Arundel County home address or report of working in Baltimore city or spending most of their waking hours in Baltimore city.
• Treatment Elsewhere (TE) arm-
• age between 18 and 75;
• Receiving methadone or buprenorphine treatment for opioid dependence at a community substance abuse treatment program;
• Baltimore City or Baltimore, Harford, Howard, or Anne Arundel County home address or report of working in Baltimore city or spending most of their waking hours in Baltimore city.

You may not qualify if:

• Daily Treatment and OBOT arm-
• History of any DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
• current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria);
• cognitive impairment severe enough to preclude informed consent or valid self-report;
• Any condition that interferes with urine collection;
• medical illness (e.g., cirrhosis, nephrotic syndrome, thyroid disease, ischemic heart disease, epilepsy, panhypopituatarism, adrenal insufficiency, etc.) or medications that, in the view of the investigators, would compromise participation in research (e.g., glucocorticoids, adrenal extract supplements, spirnolactone, pregnenolone, etc.)
• Treatment Elsewhere (TE) arm-
• History of any DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
• cognitive impairment severe enough to preclude informed consent or valid self-report;
• Any condition that interferes with urine collection.
• The self-reported use of over-the-counter or as needed medications (e.g., antacids, sleeping aids, antihistamines, etc.) for 5 days prior to the scheduled session
• Positive breathalyzer test (BAL \> 0) and/or acute intoxication from illicit drugs or alcohol
• Positive pregnancy test
• Self-report of recent pregnancy or child birth (and no resumption of normal menses)
• Failure to fast.

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 (1)

• Boardman JD, Finch BK, Ellison CG, Williams DR, Jackson JS. Neighborhood disadvantage, stress, and drug use among adults. J Health Soc Behav. 2001 Jun;42(2):151-65.

  PMID: 11467250 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brenda L Curtis, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: July 14, 2009
• Last Updated: May 4, 2026

Record last verified: 2026-04-30

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)