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Neurobiology of Alcohol and Nicotine Co-Addiction (NAUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338933
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alcohol Use Disorder Nicotine Use Disorder 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurobiology of Alcohol and Nicotine Co-Addiction
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Brain activation during functional magnetic resonance imaging (fMRI) in response to a probability and delay discounting task (PDD) [ Time Frame: 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.

  2. Brain activation during functional magnetic resonance imaging (fMRI) in response to a stress modulated cue induced craving task (DSNBACK) [ Time Frame: 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.

  3. Brain activation during resting state MRI. [ Time Frame: 1 day ]
    The magnitude of connectivity changes between groups during resting state will be assessed and reported using an ANOVA.

  4. Brain cortical density as assessed by voxel-based morphometry during MRI [ Time Frame: 1 day ]
    An ANOVA will be used to determine group differences.

  5. Brain white matter integrity as assessed by fractional anisotropy during MRI [ Time Frame: 1 day ]
    An ANOVA will be used to determine group differences


Biospecimen Retention:   Samples With DNA
Cheek swab Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • None

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338933


Contacts
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Contact: William F Hoffman, MD PhD (503) 220-8262 ext 55049 William.Hoffman2@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: William F Hoffman, MD PhD    503-220-8262 ext 55049    William.Hoffman2@va.gov   
Principal Investigator: William F Hoffman, MD PhD         
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
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Principal Investigator: William F Hoffman, MD PhD VA Portland Health Care System, Portland, OR
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03338933    
Other Study ID Numbers: NURA-002-17S
17321 ( Other Identifier: Oregon Health and Science University )
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Disease
Alcoholism
Tobacco Use Disorder
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders