NAUD: Neurobiology of Alcohol and Nicotine Co-Addiction

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03338933
Collaborator
Oregon Health and Science University (Other)
200
1
60
3.3

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Neurobiology of Alcohol and Nicotine Co-Addiction
Actual Study Start Date :
Oct 1, 2017
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. Brain cortical density as assessed by voxel-based morphometry during MRI [1 day]

    An ANOVA will be used to determine group differences.

  5. Brain white matter integrity as assessed by fractional anisotropy during MRI [1 day]

    An ANOVA will be used to determine group differences

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • None
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Portland Health Care System, Portland, OR Portland Oregon United States 97239

Sponsors and Collaborators

  • VA Office of Research and Development
  • Oregon Health and Science University

Investigators

  • Principal Investigator: William F Hoffman, MD PhD, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03338933
Other Study ID Numbers:
  • NURA-002-17S
  • 17321
First Posted:
Nov 9, 2017
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Dec 29, 2021