FMRI of Stress and Addictive Disorders
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Purpose
The purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. To examine the effect of stress on thinking and remembering. To examine the separate and interactive effects of stress, addiction, withdrawal, and genetics; and to examine fMRI brain activation associated with stressful, reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video clips in addicted individuals and in healthy controls.
| Condition |
|---|
|
Cocaine Dependence Opioid Dependence Alcoholism Pathological Gamblers Adolescents |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Functional Magnetic Resonance Imaging of Stress and Addictive Disorders |
- Neural responses to change will be measured. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 370 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cocaine dependent |
| Opioid dependent |
| Alcohol dependent |
| Healthy controls |
| Adolescents |
| Pathological gamblers |
Eligibility| Ages Eligible for Study: | 13 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers
Inclusion Criteria:
- Between ages 13-50 years old (adolescents 13-17 years old)
- Able to read and write.
- COCAINE DEPENDENT SUBJECTS: meet DSM-IV criteria for cocaine dependence; report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine toxicology screen during initial assessments and upon admission to the CNRU.
- OPIOID DEPENDENT SUBJECTS: meet DSM-IV criteria for opiate dependence and are participating in substance abuse treatment including pharmacotherapy for opioid dependence.
- ALCOHOL DEPENDENT SUBJECTS: meet DSM-IV criteria for alcohol dependence and are currently abstinent from alcohol as documented by substance abuse treatment participation.
- HEALTHY CONTROLS: negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
- Healthy adolescent boys and girls, with no medical or psychiatric conditions;
- WOMEN: have a regular menstrual cycle.
Exclusion Criteria:
- CONTROLS: lifetime or current history of any substance abuse/dependence (excluding nicotine).
- Regular use of any psychoactive drugs including anxiolytics and antidepressants.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
- Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
- IQ below 75
Contacts and Locations| Contact: Rachel L Hart, MS | 203-737-4791 | rachel.hart@yale.edu |
| Contact: Keri L Tuit, PsyD | 203-737-1176 | keri.tuit@yale.edu |
| United States, Connecticut | |
| Yale Stress Center | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Rachel L Hart, MS 203-737-4791 rachel.hart@yale.edu | |
| Contact: Keri L Tuit | |
| Principal Investigator: | Rajita Sinha, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Rajita Sinha, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT01558973 History of Changes |
| Other Study ID Numbers: | 0405026787, 2P50-DA16556-08 |
| Study First Received: | March 18, 2012 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alcoholism Opioid-Related Disorders Cocaine-Related Disorders |
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013