FMRI of Stress and Addictive Disorders

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558973

Contacts
Contact: Rachel L Hart, MS 203-737-4791 rachel.hart@yale.edu
Contact: Keri L Tuit, PsyD 203-737-1176 keri.tuit@yale.edu

Locations
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         
Sponsors and Collaborators
Yale University
Investigators
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: October 27, 2013
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 July 23, 2014