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 : October 19, 2017
|First Submitted Date||November 6, 2008|
|First Posted Date||November 7, 2008|
|Last Update Posted Date||October 19, 2017|
|Start Date||November 5, 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Real time self reported drug use and psychological stress.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00787423 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Biological indices of drug use and psychological stress: retrospective self-reports of drug use and psychosocial stress.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population|
|Official Title||Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population|
- 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.
- 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.
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.
Objective. To use Smartphones (PDAs) to measure 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 to collect ambulatory physiological and activity data in real time; and to assess the feasibility and acceptability of mobile HIV/STD Risk Reduction (HIVRR) delivered via PDA in real time.
Participant population. Opioid-dependent outpatient adults (up to 400 enrolled; up to 300 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.
Methods. Participants will undergo 22 weeks of daily methadone or buprenorphine/naloxone (henceforth buprenorphine ) maintenance and will be offered at least 8 weeks of methadone or buprenorphine taper (weeks 23-30). 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 first 18 weeks. Event-triggered entries will be initiated by participants (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 3 random-signal-triggered recordings per day and one brief end of day recording. We will compare EMA results with more traditional assessments of drug use and stress: (1) urine will be collected three times weekly during weeks 1-22 and once weekly during the optional methadone or buprenorphine taper (weeks 23-30), (2) retrospective self-report questionnaires on drug use and stress will be given regularly, and (3) laboratory session examining responsiveness to a standardized stressor will occur during the 4th 6th week. Blood draws and anthropometric measurements to assess allostatic load (a physiological marker of long-term cumulative stress) and blood samples will be obtained for genetic analysis during the 2nd 4th week. After week 12, we will also assess the impact of opioid agonist treatment on the hypothalamic-pituitary-adrenal (HPA) axis which is involved in modulating stress. After 18 weeks of opioid agonist maintenance, participants will begin an additional 4 weeks of maintenance, during which they will not carry the PDA and GPS unit unless they are participating in a secondary study that includes those measures. At the end of 22 weeks, participants will have the choice of transferring to a community clinic or undergoing an eight-week taper at the Archway clinic. Secondary studies: Up to 70 participants will be asked to wear the Daysimeter and an Actigraph activity-monitor wristwatch for 18 days (two 72-hour intervals repeated three times) and the Dimesimeter daily (24 hours/day) for 16 weeks. Up to 80 participants will be asked to wear the AutoSense for four 1-week periods, including during laboratory sessions. Up to 40 participants will be enrolled in the mHIVRR evaluation program for 4 weeks during the Maintenance Phase (completed October 2013). Up to 100 participants will be asked to wear a SleepProfiler during 7 nights to assess sleep architecture.
Primary outcome measures: (1) EMA reports of drug use and psychosocial stress, and (2) real-time assessment of environmental risk exposure as measured via integration of GPS data with the Neighborhood Psychosocial Index. Data for the methadone and buprenorphine groups will be analyzed separately for the primary outcome measures and combined as appropriate.
Secondary outcome measures: To determine the feasibility and acceptability of using (1) the Daysimeter/Dimesimeter and Actigraph to collect real-time field data on light exposure and its impact on circadian rhythms, and (2) the Autosense to collect real-time field data on physiological function. Also, to (3) 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, (4) combine Autosense data with electronic-diary data to determine if physiological responses to triggers can be used to inform drug relapse prevention efforts, (5) 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, (6) to determine if the HPA axis is normal after at least 3 months of opioid agonist treatment, (7) to incorporate genetic characteristics as predictors of EMA and GMA data and other behavioral measures, (8) 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, (9) to determine the feasibility of using a more up-to-date EMA interface and device, and to examine the relationship between opioid withdrawal symptoms and successful taper from methadone or buprenorphine maintenance and (10) to obtain qualitative data on participants perceptions of their environments, in order to inform future work and to help explain why participants seem to do better in more disordered environments.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Participants will be eligible for inclusion in the study if they meet the following criteria:
Further Exclusions and Rescheduling Criteria for All Laboratory Sessions:
Participants will be allowed to reschedule 1 time (in total, for all 3 sessions):
Other reasons for which participants may be rescheduled:
Further Inclusion/Exclusion for the HPA axis component:
Exclusions (based on impact on HPA axis and neuroendocrine function)
|Ages||18 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999909020
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )|
|Study Sponsor||National Institute on Drug Abuse (NIDA)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 28, 2017|