FMRI of Stress and Addictive Disorders

This study is currently recruiting participants.
Verified June 2013 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Rajita Sinha, Yale University
ClinicalTrials.gov Identifier:
NCT01558973
First received: March 18, 2012
Last updated: October 27, 2013
Last verified: June 2013

March 18, 2012
October 27, 2013
August 2005
June 2015   (final data collection date for primary outcome measure)
Neural responses to change will be measured. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Neural responses - BOLD signal changes. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01558973 on ClinicalTrials.gov Archive Site
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FMRI of Stress and Addictive Disorders
Functional Magnetic Resonance Imaging of Stress and Addictive Disorders

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers

  • Cocaine Dependence
  • Opioid Dependence
  • Alcoholism
  • Pathological Gamblers
  • Adolescents
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  • Cocaine dependent
  • Opioid dependent
  • Alcohol dependent
  • Healthy controls
  • Adolescents
  • Pathological gamblers
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
370
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
13 Years to 50 Years
Yes
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
 
NCT01558973
0405026787, 2P50-DA16556-08
Yes
Rajita Sinha, Yale University
Yale University
  • National Institutes of Health (NIH)
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Rajita Sinha, PhD Yale University
Yale University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP