NCT01558973

Completed

FMRI of Stress and Addictive Disorders

Yale University Source

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Other study identifiers

Sponsor study identifier

0405026787

Secondary identifiers

2P50DA016556-08

NIH

Study Type

observational

Actual enrollment (reported)

108

Locations

1 country

Sites

1

Timeline

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Actual (reported)

Study Completion

Not reported

Date not reported

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 108 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 18, 2012
Actual (reported)
First Posted
March 20, 2012
Actual (reported)
Primary Completion
December 2015
Actual (reported)

Last Updated: November 30, 2016
Status Verified: November 2016
Last Update Submitted: November 28, 2016

Conditions

Adolescents Alcoholism Cocaine Dependence Opioid Dependence Pathological Gamblers

Outcome Measures

Primary Outcomes (1)

Neural responses to change will be measured.
Baseline

Study Arms (6)

Cocaine dependent

Opioid dependent

Alcohol dependent

Healthy controls

Adolescents

Pathological gamblers

Eligibility Criteria

Age13 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers

You may qualify if:

Between ages 13-50 years old (adolescents 13-17 years old)

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHcollaborator
Yale University
Otherlead
National Institutes of Health (NIH)

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related DisordersAlcohol-Related Disorders

Study Officials

Rajita Sinha, PhD
Yale University
PRINCIPAL INVESTIGATOR

Enrollment

108 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 18, 2012

First Posted

March 20, 2012

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

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Phase 4Completed

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

NIHcollaborator

Primary Completion

December 2015

Actual (reported)

Last Updated

November 30, 2016

Record last verified: 2016-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01558973
Data provider: ClinicalTrials.gov
Source updated: 2016-11-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:27 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (6)

Cocaine dependent

Opioid dependent

Alcohol dependent

Healthy controls

Adolescents

Pathological gamblers

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations