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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00787423
First received: November 6, 2008
Last updated: March 15, 2014
Last verified: December 2013
  Purpose

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.

Condition
Psychological Stress
Drug Abuse

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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

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

Estimated Enrollment: 400
Study Start Date: October 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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 County home address or report of working in Baltimore city or spending most of their waking hours in Baltimore city.

EXCLUSION CRITERIA:

  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

Additional Exclusionary and Rescheduling Criteria will be enforced for the Cold Pressor portion of the protocol:

-Self-reported and/or observed signs, symptoms, or diagnosis of Raynaud s or Buerger s disease (e.g., pain in hands or feet at times of rest, during/following cold exposure or stress, any significant color changes in hands or toes). Additionally, medical staff will be present to watch for these symptoms during the actual test.

Further Inclusion/Exclusion for the HPA axis component:

Inclusion

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787423

Contacts
Contact: Kenzie Preston, Ph.D. (443) 740-2326 kpreston@intra.nida.nih.gov

Locations
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    researchstudies@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Kenzie Preston, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00787423     History of Changes
Other Study ID Numbers: 999909020, 09-DA-N020
Study First Received: November 6, 2008
Last Updated: March 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

ClinicalTrials.gov processed this record on August 28, 2014