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

Study Description

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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
Psychological Stress; Drug Abuse

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Study Design

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Study Type :	Observational
Estimated Enrollment :	500 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

Groups and Cohorts

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Outcome Measures

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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.

Eligibility Criteria

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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

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 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:

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:

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:

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

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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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Kenzie Preston, Ph.D.	National Institute on Drug Abuse (NIDA)

More Information

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Publications:

Allsworth JE, Weitzen S, Boardman LA. Early age at menarche and allostatic load: data from the Third National Health and Nutrition Examination Survey. Ann Epidemiol. 2005 Jul;15(6):438-44.

Björntorp P. Body fat distribution, insulin resistance, and metabolic diseases. Nutrition. 1997 Sep;13(9):795-803. Review.

Boardman JD, Finch BK, Ellison CG, Williams DR, Jackson JS. Neighborhood disadvantage, stress, and drug use among adults. J Health Soc Behav. 2001 Jun;42(2):151-65.

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
Last Update Posted:	August 15, 2018
Last Verified:	August 10, 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