Neurobiology of Alcohol and Nicotine Co-Addiction

Completed

• Conditions: Alcohol Use Disorder; Nicotine Use Disorder
• Interventions: Behavioral: magnetic resonance imaging (MRI)

• Registration Number: NCT03338933
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users.

Detailed Description

This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S. Co-addiction is particularly high in military veterans. Although nationwide estimates peg the rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated for AUD also meet criteria for NUD. The investigators hypothesize that a support vector machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD both or neither and that the algorithm will predict outcome (sobriety or relapse) at three months.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• None

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nicotine Group	magnetic resonance imaging (MRI)	Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria for Nicotine Use Disorder. Current smoker, at least 10 cigarettes per day. No history of addiction to any other substance
Control Group	magnetic resonance imaging (MRI)	No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.
Nicotine and Alcohol Group	magnetic resonance imaging (MRI)	DSM-V criteria for Nicotine Use Disorder and Alcohol Use Disorder. At least 8 heavy drinking episodes in the past month. Current smoker. Alcohol free from 2 to 4 weeks. No history of addiction to other substances or gambling.
Alcohol Group	magnetic resonance imaging (MRI)	DSM-V criteria for Alcohol use Disorder. At least 8 heavy drinking episodes in the past month. Abstinent for at least 2 weeks and no more than 4 weeks. Less than 20 lifetime cigarettes or equivalent. No history of addiction to any other substances or gambling.

Primary Outcome Measures

Name	Time	Method
Brain white matter integrity as assessed by fractional anisotropy during MRI	1 day	An ANOVA will be used to determine group differences
Brain activation during functional magnetic resonance imaging (fMRI) in response to a probability and delay discounting task (PDD)	1 day	An analysis of variance (ANOVA) test will be used to assess group differences (AUD, NUD, NAUD, and CS) in parametric brain activation during the PDD.
Brain cortical density as assessed by voxel-based morphometry during MRI	1 day	An ANOVA will be used to determine group differences.
Brain activation during functional magnetic resonance imaging (fMRI) in response to a stress modulated cue induced craving task (DSNBACK)	1 day	An ANOVA will be used to assess group differences (AUD, NUD, NAUD, and CS) in brain activation that scales parametrically with the DSNBACK.
Brain activation during resting state MRI.	1 day	The magnitude of connectivity changes between groups during resting state will be assessed and reported using an ANOVA.

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States