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NCT00787423

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

Sponsor: National Institute on Drug Abuse (NIDA)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

373

Start Date

2009-07-14

Completion Date

Not specified

Last Updated

2026-04-24

Healthy Volunteers

Conditions

Stress Drug Abuse

* 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

Locations (1)

National Institute on Drug Abuse

Baltimore, Maryland, United States