FMRI of Stress and Addictive Disorders

NCT ID: NCT01558973

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cocaine Dependence Opioid Dependence Alcoholism Pathological Gamblers Adolescents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cocaine dependent

No interventions assigned to this group

Opioid dependent

No interventions assigned to this group

Alcohol dependent

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Adolescents

No interventions assigned to this group

Pathological gamblers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Rajita Sinha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajita Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Stress Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2P50DA016556-08

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0405026787

Identifier Type: -

Identifier Source: org_study_id