Measuring Distress Tolerance With Functional MRI

Completed

Conditions studied: Cocaine Dependence

In brief

Background: \- People who are in treatment for substance abuse often feel distress during the withdrawal period and afterward. Some individuals feel distress more acutely than others, and this distress has been linked to poor treatment outcomes and increased risk of relapse in smokers, alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the effects of distress on the brain, particularly in individuals who are seeking treatment for substance abuse. Researchers are interested in using functional magnetic resonance imaging (fMRI) scanning to study distress tolerance in both substance users seeking treatment and healthy non-drug-using volunteers. Objectives: \- To use functional magnetic resonance imaging to study the effectiveness of a distress tolerance assessment. Eligibility: \- Individuals between 18 and 50 years of age who are either cocaine dependent or healthy non-drug-using volunteers. Design: * This study involves an initial screening visit and a scanning visit, with four followup visits. * Participants will be screened with a medical history and physical examination, as well as blood samples and questionnaires about mood and past and current drug use. * Participants will have a structural MRI scan of the brain to provide a baseline reading for comparison. Participants will then have an fMRI scanning session, which will include both the distress tolerance assessment and relevant control tasks. Heart rate, blood pressure, and other physical reactions will be monitored throughout the scan. Participants will also provide blood and saliva samples to measure stress hormone levels. * Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6, and 12 months after the scanning visit.

Key facts

Study ID

NCT01038232

Run by

National Institute on Drug Abuse (NIDA)

People needed

99

Starts

2009-12-04

Expected to finish

2015-03-24

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing age before each experimental session.
• Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
• Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
• Have current major psychiatric disorders to include, but not limited to, mood, anxiety, borderline personality disorder, psychotic disorders, or substance-induced psychiatric disorders,
• Have neurological illnesses including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
• Control participants: Meet DSM-IV criteria for any past or current substance abuse or dependence; use of illicit substances in the last 30 days or nicotine if use is greater than 10 cigarettes per day and/or Fagerstrom score is greater than 3.
• Cocaine using participants:
• Non-treatment subjects: Meet DSM-IV criteria for substance dependence on any substance other than nicotine or cocaine in the month prior to study enrollment. Only (except nicotine or cocaine dependence will be allowed in the month prior to enrollment. Current abuse on any substance will be acceptable.). While it might be preferable to exclude individuals whose use of other substances reaches the threshold of abuse, inclusion of such individuals will not necessarily contaminate the data.
• Inpatient cocaine subjects: Those who meet DSM-IV TR criteria for the course specifier In a Controlled Environment may have a history of dependence on substances other than cocaine before their admission to the inpatient treatment program.
• Regular use of any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling. Medications that could interfere with the BOLD signal include compounds that have been shown to be vasoactive, including alpha agonists, beta blockers, and calcium channel blockers.
• Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above).
• Acute drug intoxication or positive urine drug screen at the beginning of the study

Where it is running

• National Institute on Drug Abuse, Biomedical Research Center (BRC) — Baltimore, Maryland, United States
• University of Maryland, College Park — College Park, Maryland, United States

Full record on ClinicalTrials.gov

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