Status:
COMPLETED
Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Stress
Drug Abuse
Eligibility:
All Genders
18+ years
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 environ...
Detailed Description
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 Feb...
Eligibility Criteria
Inclusion
- 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.
- EXCLUSION CRITERIA:
- 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-
- 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
Exclusion
Key Trial Info
Start Date :
July 14 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00787423
Start Date
July 14 2009
Last Update
January 8 2026
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224