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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1
Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alcohol Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and females, aged 18-60 years;
  • Good health as verified by screening examination;
  • Able to read English and complete study evaluations;
  • Able to provide informed written and verbal consent;
  • AD sample must meet DSM-5 criteria for AUD as assessed using SCID-I and have positive alcohol urine toxicology screens on admission to study; while HC group must never have met criteria for AUD, with non-binging and nonhazardous alcohol intake levels( men: below15 drinks/week; women: less than 8 drinks/week); and with negative alcohol urine toxicology screens; Page

Exclusion Criteria:

  • Meet current criteria for dependence on another psychoactive substance, excluding nicotine; (ii) Current use of opiates or past history of opiate abuse/dependence;
  • Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrhythmics, antiretroviral medications, SSRI's naltrexone, antabuse;
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the course of the study;
  • Any psychotic disorder or current Axis I psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications;
  • hypotensive individuals with sitting blood pressure below 90/50 mmHG;
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study); and
  • those with metal in their body excluded from MRI due to safety.

Sites / Locations

  • Yale Stress Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Treatment Seeking Alcohol Dependent Adults

Social Drinking Controls

Prazosin/Placebo Group

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

Time to Relapse
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days, during the study and during follow-up until relapse occurs or 200 days is up.

Secondary Outcome Measures

Time to heavy drinking relapse
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days (this is standard for TLFB surveys), during the study and during follow-up until relapse occurs or 200 days is up.
Percent of days of alcohol use in follow-up
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days (which is standard for TLFB surveys), during the study and during follow-up. This can only be measured once relapse occurs. It will be measured once relapse occurs or will not be measured at all if relapse does not occur within 200 days.

Full Information

First Posted
November 16, 2015
Last Updated
April 13, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02616094
Brief Title
Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse
Official Title
Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Extending previous findings, and applying a novel multi-method translational approach, this project hypothesizes that there are alcohol-related neuroendocrine and neural changes observable in acute and protracted abstinence, and which can accurately classify future relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby validating them as biomarkers of relapse, with potential clinical utility as prognostic markers in identifying and treating those most susceptible to relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Seeking Alcohol Dependent Adults
Arm Type
Experimental
Arm Description
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.
Arm Title
Social Drinking Controls
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prazosin/Placebo Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1
Intervention Description
The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.
Intervention Type
Device
Intervention Name(s)
Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2
Intervention Description
The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.
Primary Outcome Measure Information:
Title
Time to Relapse
Description
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days, during the study and during follow-up until relapse occurs or 200 days is up.
Time Frame
Up to 200 days
Secondary Outcome Measure Information:
Title
Time to heavy drinking relapse
Description
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days (this is standard for TLFB surveys), during the study and during follow-up until relapse occurs or 200 days is up.
Time Frame
Up to 200 days
Title
Percent of days of alcohol use in follow-up
Description
The Time-Line Follow-Back Interview will be used to assess alcohol use in the previous ninety days (which is standard for TLFB surveys), during the study and during follow-up. This can only be measured once relapse occurs. It will be measured once relapse occurs or will not be measured at all if relapse does not occur within 200 days.
Time Frame
Up to 200 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and females, aged 18-60 years; Good health as verified by screening examination; Able to read English and complete study evaluations; Able to provide informed written and verbal consent; AD sample must meet DSM-5 criteria for AUD as assessed using SCID-I and have positive alcohol urine toxicology screens on admission to study; while HC group must never have met criteria for AUD, with non-binging and nonhazardous alcohol intake levels( men: below15 drinks/week; women: less than 8 drinks/week); and with negative alcohol urine toxicology screens; Page Exclusion Criteria: Meet current criteria for dependence on another psychoactive substance, excluding nicotine; (ii) Current use of opiates or past history of opiate abuse/dependence; Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrhythmics, antiretroviral medications, SSRI's naltrexone, antabuse; Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania); Significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the course of the study; Any psychotic disorder or current Axis I psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications; hypotensive individuals with sitting blood pressure below 90/50 mmHG; Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study); and those with metal in their body excluded from MRI due to safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Stress Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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