Overview

This trial has been completed.

Conditions cocaine dependence, opioid dependence, alcoholism, pathological gamblers, adolescents
Sponsor Yale University
Collaborator National Institutes of Health (NIH)
Start date August 2005
End date December 2015
Trial size 108 participants
Trial identifier NCT01558973, 0405026787, 2P50DA016556-08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Neural responses to change will be measured.
time frame: Baseline

Eligibility Criteria

Male or female participants from 13 years up to 50 years old.

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

Additional Information

Official title Functional Magnetic Resonance Imaging of Stress and Addictive Disorders
Principal investigator Rajita Sinha, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.