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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00787423
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

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.

Condition or disease
Stress Drug Abuse

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Study Type : Observational
Actual Enrollment : 371 participants
Observational Model: Cohort
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
Actual Study Start Date : July 14, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
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.



Primary Outcome Measures :
  1. Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index [ Time Frame: real-time assessment ]
    Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index

  2. EMA reports of drug use and psychosocial stress [ Time Frame: real-time assessment ]
    EMA reports of drug use and psychosocial stress


Secondary Outcome Measures :
  1. 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 [ Time Frame: Ongoing ]
    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

  2. To evaluate sleep quality in relationship to drug use and stress exposure [ Time Frame: Ongoing ]
    To evaluate sleep quality in relationship to drug use and stress exposure

  3. Incorporate genetic characteristics as predictors of EMA and GMA data and other behavioral measures [ Time Frame: Ongoing ]
    Incorporate genetic characteristics as predictors of EMA and GMA data and other behavioral measures

  4. To determine if the HPA axis is normal after at least 3 months of opioid agonist treatment [ Time Frame: Ongoing ]
    To determine if the HPA axis is normal after at least 3 months of opioid agonist treatment

  5. Determine the feasibility of using a more up-to-date EMA interface and device [ Time Frame: Ongoing ]
    Determine the feasibility of using a more up-to-date EMA interface and device

  6. To assess how objectively measured sleep quality is associated with EMA-reported psychosocial stress and reward responsiveness, and with geographical exposure to stressful and rewarding environments [ Time Frame: Ongoing ]
    To assess how objectively measured sleep quality is associated with EMA-reported psychosocial stress and reward responsiveness, and with geographical exposure to stressful and rewarding environments

  7. Accuracy and helpfulness of the Health Tag [ Time Frame: Ongoing ]
    Accuracy and helpfulness of the Health Tag

  8. Combine Autosense data with electronic-diary data to determine if physiological responses to triggers can be used to inform drug relapse prevention efforts [ Time Frame: Ongoing ]
    Combine Autosense data with electronic-diary data to determine if physiological responses to triggers can be used to inform drug relapse prevention efforts

  9. Combine Daysimeter/Dimesimeter data with electronic-diary data to determine whether heroin/cocaine users experience circadian disruption and, if so, how this disruption is related to psychosocial stress and illicit drug use [ Time Frame: Ongoing ]
    Combine Daysimeter/Dimesimeter data with electronic-diary data to determine whether heroin/cocaine users experience circadian disruption and, if so, how this disruption is related to psychosocial stress and illicit drug use

  10. Feasibility and acceptability of using the Autosense to collect real-time field data on physiological function [ Time Frame: Ongoing ]
    Feasibility and acceptability of using the Autosense to collect real-time field data on physiological function

  11. Feasibility and acceptability of using the Daysimeter/Dimesimeter and Actigraph to collect real-time field data on light exposure and its impact on circadian rhythms [ Time Frame: Ongoing ]
    Feasibility and acceptability of using the Daysimeter/Dimesimeter and Actigraph to collect real-time field data on light exposure and its impact on circadian rhythms

  12. To determine the feasibility of using passively collected smartphone data to assess physical activity and social interactions to infer daily behaviors, such as physical movement (activity, mobility patterns) and social interactions (computer-med... [ Time Frame: Ongoing ]
    To determine the feasibility of using passively collected smartphone data to assess physical activity and social interactions to infer dailybehaviors, such as physical movement (activity, mobility patterns) and social interactions (computer mediated communications)

  13. To describe and analyze differences in the frequency and content of dialogue on social media to determine the words or phrases associated with drug use; drug treatment; recovery; and risk and protective factors for drug use (e.g., stress levels,... [ Time Frame: Ongoing ]
    To describe and analyze differences in the frequency and content of dialogue on social media to determine the words or phrases associated with drug use; drug treatment; recovery; and risk and protective factors for drug use (e.g., stress levels, anxiety, depression, social support).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).@@@@@@
Criteria
  • INCLUSION CRITERIA:

Daily Treatment and OBOT arm-

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.

Treatment Elsewhere (TE) arm-

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

  1. age between 18 and 75;
  2. Receiving methadone or buprenorphine treatment for opioid dependence at a community substance abuse treatment program;
  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.

EXCLUSION CRITERIA:

Daily Treatment and OBOT arm-

  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.)

Treatment Elsewhere (TE) arm-

  1. History of any DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
  2. cognitive impairment severe enough to preclude informed consent or valid self-report;
  3. Any condition that interferes with urine collection.

Further exclusions and rescheduling criteria for all laboratory sessions-

  • 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.

Participants will be allowed to reschedule 1 time (in total, for the 2 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-

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)

  • HIV+
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00787423


Locations
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United States, Maryland
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Brenda Curtis, Ph.D. National Institute on Drug Abuse (NIDA)
Publications:
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00787423    
Other Study ID Numbers: 999909020
09-DA-N020
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: June 16, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Field Tools
Stress
Psychological Stress
Ecological Monetary Assessment (EMA)
Global Positioning Units
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders