We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

FMRI of Stress and Addictive Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558973
First Posted: March 20, 2012
Last Update Posted: November 30, 2016
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. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rajita Sinha, Yale University
  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

Further study details as provided by Rajita Sinha, Yale University:

Primary Outcome Measures:
  • Neural responses to change will be measured. [ Time Frame: Baseline ]

Enrollment: 108
Study Start Date: August 2005
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cocaine dependent
Opioid dependent
Alcohol dependent
Healthy controls
Adolescents
Pathological gamblers

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers
Criteria

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
Information from the National Library of Medicine

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): NCT01558973


Locations
United States, Connecticut
Yale Stress Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University
  More Information

Responsible Party: Rajita Sinha, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01558973     History of Changes
Other Study ID Numbers: 0405026787
2P50DA016556-08 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2012
First Posted: March 20, 2012
Last Update Posted: November 30, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders