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

Not Applicable

Completed

• Conditions: Alcohol Dependence
• Interventions: Device: Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1; Device: Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2

• Registration Number: NCT02616094
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Seeking Alcohol Dependent Adults	Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2	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.
Prazosin/Placebo Group	Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1	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.
Treatment Seeking Alcohol Dependent Adults	Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1	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.
Social Drinking Controls	Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1	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.
Prazosin/Placebo Group	Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2	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.

Primary Outcome Measures

Name	Time	Method
Time to Relapse	Up to 200 days	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

Name	Time	Method
Time to heavy drinking relapse	Up to 200 days	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	Up to 200 days	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.

Trial Locations

Locations (1)

Yale Stress Center; 🇺🇸 New Haven, Connecticut, United States