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

NCT00787423 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 373

Last updated 2026-05-22

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Brenda L Curtis, Ph.D. · National Institute on Drug Abuse (NIDA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787423 on ClinicalTrials.gov