Neurobiology of Alcohol and Nicotine Co-Addiction

Alcohol Use Disorder Clinical Trial

— NAUD  

Official title:

Neurobiology of Alcohol and Nicotine Co-Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338933
• Other study ID #: NURA-002-17S
• Secondary ID: 17321
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• None

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Brain cortical density as assessed by voxel-based morphometry during MRI	An ANOVA will be used to determine group differences.	1 day
Primary	Brain white matter integrity as assessed by fractional anisotropy during MRI	An ANOVA will be used to determine group differences	1 day