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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616094
• Other study ID #: 1501015225
• Secondary ID: 2R01AA013892-11
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Device:
• Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1
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.
• Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2
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.

Locations

Country	Name	City	State
United States	Yale Stress Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 200 days
Secondary	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.	Up to 200 days
Secondary	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.	Up to 200 days