FMRI of Stress and Addictive Disorders

Alcoholism Clinical Trial

Official title:

Functional Magnetic Resonance Imaging of Stress and Addictive Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558973
• Other study ID #: 0405026787
• Secondary ID: 2P50DA016556-08
• Status: Completed
• Phase: N/A
• First received: March 18, 2012
• Last updated: November 28, 2016
• Start date: August 2005

Study information

• Verified date: November 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adolescents
• Alcoholism
• Cocaine Dependence
• Cocaine-Related Disorders
• Opioid Dependence
• Pathological Gamblers

Locations

Country	Name	City	State
United States	Yale Stress Center	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural responses to change will be measured.		Baseline	No