Neurobiology of Alcohol and Nicotine Co-Addiction (NAUD)

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

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Nicotine Use Disorder
• Intervention / Treatment: Behavioral: magnetic resonance imaging (MRI)

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the Portland VA, Oregon Health & Science University, community substance abuse treatment programs and by advertisement.

Description

Inclusion Criteria:

• None

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; No history of addiction to any substance or gambling. Less than 20 lifetime cigarettes or equivalent.	Behavioral: magnetic resonance imaging (MRI); All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.
Nicotine Group; 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	Behavioral: magnetic resonance imaging (MRI); All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.
Nicotine and Alcohol Group; 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.	Behavioral: magnetic resonance imaging (MRI); All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.
Alcohol Group; 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.	Behavioral: magnetic resonance imaging (MRI); All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: William F Hoffman, MD PhD, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Tobacco Use Disorder
• Other Study ID Numbers: NURA-002-17S; 17321 (Other Identifier: Oregon Health and Science University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No