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Completed

NCT Number: NCT02616094

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Stress Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1

Device

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

Device

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 outcomes

  1. Time to Relapse

    Time frame: 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 outcomes

  1. Time to heavy drinking relapse

    Time frame: 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.

  2. Percent of days of alcohol use in follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2015
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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