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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00787423
Recruitment Status : Recruiting
First Posted : November 7, 2008
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

Brief Summary:


- 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.


- 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.


  • 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.


  • 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.

Condition or disease
Psychological Stress Drug Abuse

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Prospective
Official Title: Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
Study Start Date : November 5, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Primary Outcome Measures :
  1. Real time self reported drug use and psychological stress.

Secondary Outcome Measures :
  1. Biological indices of drug use and psychological stress: retrospective self-reports of drug use and psychosocial stress.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Participants will be eligible for inclusion in the study if they meet the following criteria:

  1. Age between 18 and 75
  2. Physical dependence on opioids (by positive urine and/or frank opioid withdrawal)
  3. 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.


  1. History of any DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder
  2. Current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria)
  3. Cognitive impairment severe enough to preclude informed consent or valid self-report
  4. Any condition that interferes with urine collection
  5. 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.)

Further Exclusions and Rescheduling Criteria for All Laboratory Sessions:

  1. 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
  2. Positive breathalyzer test (BAL > 0) and/or acute intoxication from illicit drugs or alcohol
  3. Positive pregnancy test
  4. Self-report of recent pregnancy or child birth (and no resumption of normal menses)
  5. Failure to fast.

Participants will be allowed to reschedule 1 time (in total, for all 3 sessions):

Other reasons for which participants may be rescheduled:

  • They report significant recent health (e.g. influenza, infection, wound) or emotional (e.g. death in the family) events.
  • Are late for session

Further Inclusion/Exclusion for the HPA axis component:


  • Receiving buprenorphine agonist therapy (dose range 16-24 mg)
  • Stable buprenorphine dose for 30 days prior

Exclusions (based on impact on HPA axis and neuroendocrine function)

  • HIVpositive
  • Pregnancy

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 identifier (NCT number): NCT00787423

Contact: Kenzie Preston, Ph.D. (443) 740-2326

United States, Maryland
National Institute on Drug Abuse Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kenzie Preston, Ph.D. National Institute on Drug Abuse (NIDA)

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT00787423     History of Changes
Other Study ID Numbers: 999909020
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 9, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Field Tools
Drug Use
Psychological Stress
Ecological Momentary Assessment
Global Positioning Units

Additional relevant MeSH terms:
Substance-Related Disorders
Stress, Psychological
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms