Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00787423|
Recruitment Status : Recruiting
First Posted : November 7, 2008
Last Update Posted : March 21, 2018
- 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.
- 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.
- 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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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.
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) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Kenzie Preston, Ph.D.||National Institute on Drug Abuse (NIDA)|