Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index
研究概览
简要总结
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.
详细描述
Background. This protocol arose in response to NIH s Genes and Environment Initiative (GEI). There is no genetic component to this protocol (update: no genetics initially but added by amendment in February 2013); rather, the goal is to develop field-deployable measures of environmental influences (stressors, drug exposure, etc.) that can ultimately be used in studies of gene-environment interactions.
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Objective. To use smartphones as electronic diaries (EDs) and passive data collection tools to measure geographical location, physical activity, social interactions, stress and drug use; Global Positioning System (GPS) units to assess geographical location; biological samples for genetic testing; Daysimeters and Dimesimeters to assess circadian rhythm; AutoSense and Health Tag to collect ambulatory physiological and activity data in real time; social media language to assess content associated with stress and drug use; and to assess the feasibility and acceptability of mobile HIV/STD Risk Reduction (HIVRR) or stress-reduction intervention with feedback from Health Tag delivered via ED in real time.
Participant 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).
Experimental design. A natural-history study of stress (both personal and environmental) and drug use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Daily Treatment and OBOT arm-
- •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.
- •Treatment Elsewhere (TE) arm-
- •Participants will be eligible for inclusion in the study if they meet the following criteria:
- •age between 18 and 75;
- •Receiving methadone or buprenorphine treatment for opioid dependence at a community substance abuse treatment program;
- •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.
排除标准
- •Daily Treatment and OBOT arm-
- •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.)
- •Treatment Elsewhere (TE) arm-
- •History of any DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
- •cognitive impairment severe enough to preclude informed consent or valid self-report;
- •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-
- •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)
- •Pregnancy
研究组 & 干预措施
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.
结局指标
主要结局
Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index
时间窗: real-time assessment
Real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index
EMA reports of drug use and psychosocial stress
时间窗: real-time assessment
EMA reports of drug use and psychosocial stress
次要结局
- 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(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(Ongoing)
- Incorporate genetic characteristics as predictors of EMA and GMA data and other behavioral measures(Ongoing)
- Combine Autosense data with electronic-diary data to determine if physiological responses to triggers can be used to inform drug relapse prevention efforts(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,...(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(Ongoing)
- To evaluate sleep quality in relationship to drug use and stress exposure(Ongoing)
- To determine if the HPA axis is normal after at least 3 months of opioid agonist treatment(Ongoing)
- Accuracy and helpfulness of the Health Tag(Ongoing)
- Determine the feasibility of using a more up-to-date EMA interface and device(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(Ongoing)
- Feasibility and acceptability of using the Autosense to collect real-time field data on physiological function(Ongoing)
- 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...(Ongoing)