Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
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ClinicalTrials.gov Identifier: NCT00787423 |
Recruitment Status
:
Recruiting
First Posted
: November 7, 2008
Last Update Posted
: March 21, 2018
|
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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 |
---|
Psychological Stress Drug Abuse |

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 |

- Real time self reported drug use and psychological stress.
- Biological indices of drug use and psychological stress: retrospective self-reports of drug use and psychosocial stress.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
Participants will be eligible for inclusion in the study if they meet the following criteria:
- 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.
EXCLUSION CRITERIA:
- 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.)
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 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:
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

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
Contact: Kenzie Preston, Ph.D. | (443) 740-2326 | kpreston@intra.nida.nih.gov |
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 |
Principal Investigator: | Kenzie Preston, Ph.D. | National Institute on Drug Abuse (NIDA) |
Publications:
Responsible Party: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00787423 History of Changes |
Other Study ID Numbers: |
999909020 09-DA-N020 |
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 |