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Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2 for Alcoholism

N/A

Waitlist Available

Led By Rajita Sinha, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 200 days

Awards & highlights

Study Summary

This trial finds that there are physical changes in the brain and endocrine system that can predict if an alcoholic will relapse, and that these changes could be used as biomarkers to help treat alcoholism.

Eligible Conditions

Alcoholism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 200 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 200 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 200 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Relapse

Secondary outcome measures

Percent of days of alcohol use in follow-up

Time to heavy drinking relapse

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Seeking Alcohol Dependent AdultsExperimental Treatment2 Interventions

Group consists of 100 treatment seeking alcohol dependent (AD) men and women (ages 18-60). AD subjects will complete either 8 weeks of outpatient treatment at the Yale Stress Center, or the first 4 weeks as inpatient treatment at the CNRU, followed by 4 weeks of outpatient treatment at the Yale Stress Center. While in outpatient treatment, AD subjects may be admitted to the CNRU or HRU for the 1-5 days prior to one or both of their scans, to ensure abstinence for their scans.

Group II: Prazosin/Placebo GroupActive Control2 Interventions

This is a separate group of 60 treatment seeking AD subjects in a NIAAA-funded RCT of Prazosin vs placebo for alcohol dependence ( PI: Sinha, Hic protocol 0705002691, NCT00585780) to assess target primary and secondary predictors of alcohol treatment outcomes in the context of a currently ongoing RCT. AD subjects enrolled in the PZ/PL RCT will NOT be given drugs as part of this study. That study and intervention is listed elsewhere (NCT00585780). Subjects will participate in a baseline scan and a second scan between weeks 10-12 of the 12-week RCT with follow-ups. PZ/PL is only given to subjects enrolled in 0705002691, not the current protocol.

Group III: Social Drinking ControlsActive Control1 Intervention

Group consists of demographically and handedness matched 50 socially drinking controls. Healthy controls will be moderate and binge/heavy social drinkers who will participate in a single MRI session after baseline assessments. Healthy controls may be admitted to the HRU overnight prior to their scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2

2015

N/A

~230

Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1

2015

N/A

~230

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Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,594 Total Patients Enrolled

84 Trials studying Alcoholism

10,155 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,773 Total Patients Enrolled

423 Trials studying Alcoholism

985,484 Patients Enrolled for Alcoholism

Rajita Sinha, PhDPrincipal InvestigatorYale University

13 Previous Clinical Trials

1,875 Total Patients Enrolled

4 Trials studying Alcoholism

392 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment for this trial open at the present time?

"According to clinicaltrials.gov, this particular trial is not actively recruiting at the moment; it was first posted on November 1st 2015 and last updated 22nd July 2022. Nevertheless, there are 268 other studies that could use participants right now."

Answered by AI

Is participation in this study limited to individuals under 75 years old?

"The requirements for participation in this medical research stipulate that patients must be between 18 and 60 years old. For minors, there are 20 studies available, while adults older than 65 can partake in 199 different trials."

Answered by AI

What are the eligibility requirements for participation in this research?

"This clinical trial is seeking 224 participants that have a diagnosis of alcoholism and range in age from 18 to 60. Those who are accepted must be able to supply both written and verbal consent, while also being male or female within the specified ages."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse

2015. "Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02616094.