Sleep and Emotional Reactivity in Alcohol Use Disorder

NCT04979507 | Unknown

• 2 other identifiers: Pro000453711R21AA028617-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol use disorder (AUD) is a multifaceted, chronic relapsing disorder suffered by millions of men and women in the United States. AUD is associated with disrupted sleep continuity and architecture, which impact health-related quality of life, and contribute to relapse. However, many alcohol-sleep interactions and their underlying mechanisms remain unclear, especially those involving AUD and chronic sleep problems. Rapid eye movement (REM) sleep is altered long into abstinence, with excess duration and intensity of REM sleep, which is a predictor of relapse. Emotion deficits, including affective flattening and mesocorticolimbic hypo-responsiveness to emotional stimuli, are also consistent findings in AUD and predictors of relapse. Here, our investigators bring these two components together, building on an emerging literature showing that REM sleep is important for neural emotion regulation, calibrating emotions to promote next-day adaptive emotional functioning. Our investigators propose that the REM sleep-emotion pathway is dysfunctional in AUD, contributing to the deficits in emotion regulation in AUD shown by us and others, which could then lead to increased craving and relapse. Our investigators study male and female AUD patients compared to age- and gender-matched healthy controls, using 2 within-subject sleep conditions: uninterrupted sleep; selective REM sleep reduction, followed by functional neuroimaging with emotion reactivity and regulation tasks the following morning. Our investigators aim to determine specific effects of experimental REM sleep reduction on next-day neural emotional reactivity in AUD compared to healthy controls and compared to a night of uninterrupted sleep

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (2)

• Measures of neural emotional reactivity among emotional networks in AUD

  Brain activation and functional connectivity measures in amygdala and prefrontal cortex derived from fMRI tasks on emotional reactivity and regulation after a night of uninterrupted sleep compared to a night of selective REM sleep reduction in a group of AUD individuals and healthy controls (CTL).

  Through study completion, an average of 1 year

• Measures of functional connectivity among emotional networks in AUD

  Brain activation and functional connectivity measures in amygdala and prefrontal cortex derived from fMRI tasks on emotional reactivity and regulation after a night of uninterrupted sleep compared to a night of selective REM sleep reduction in a group of AUD individuals and healthy controls (CTL).

  Through study completion, an average of 1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

Other: Uninterrupted sleep followed by functional neuroimaging.

Control group

ACTIVE COMPARATOR

Other: Uninterrupted sleep followed by functional neuroimaging.

Interventions

Uninterrupted sleep followed by functional neuroimaging. OTHER

2 within-subject sleep conditions: uninterrupted sleep; selective REM sleep reduction, followed by functional neuroimaging with emotion reactivity and regulation tasks the following morning

Control group; Experimental Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-65 years, with age range matching our past sleep and MRI protocols in AUD; encompassing the young-middle age range for adults, allowing at least a 5 year drinking history for AUD and outside of adolescence (younger cut-off) and before substantial age-related impact on sleep and health (older cut-off);
• Male, female;
• At least 8 years of education;
• Meet cut-off criteria on cognitive tests (MoCA, \> 23, WTAR,\> 85)104,105,126
• Meet clinical DSM 5 criteria for alcohol use disorder with at least a 5 year drinking history (AUD group) or not meet clinical DSM 5 criteria for any psychiatric disorder (Control group).
• Be at least 6 months abstinent, up to 36 months abstinent, based on 2,13,35 showing that REM sleep excess is evident

You may not qualify if:

• History of medical or neurological illness or trauma that would affect the central nervous system (e.g., stroke, multiple sclerosis, epilepsy)
• History of loss of consciousness over 30 min, compound skull fracture or clear neurological sequelae;
• Greater than mild past other substance use disorder and/or current other substance use disorder not in remission (\< 1 year since meeting criteria) (AUD only)
• Current post-traumatic stress disorder and/or generalized anxiety disorder;
• Current clinical diagnosis of moderate-severe substance use disorder (other than alcohol)
• History of schizophrenia or bipolar disorder;
• Current severe medical conditions (e.g. uncontrolled Diabetes, chemotherapy for cancer);
• Current use of benzodiazepine, hypnotic, or anti-depressant medications;
• Shift work in the six months prior to the study;
• Moderate-severe sleep-disordered breathing (apnea-hypopnea index 15 or greater at the clinical PSG);
• Periodic Limb Movements (PLM) Disorder with a PLM arousal index greater than 10 events per hour at the clinical PSG;
• Pregnant;
• Current use of drugs or alcohol at clinical visits (positive drug screen or breathalyzer \> 0);
• MRI contraindications, such as: irremovable metal implements, cardiac pacemakers, claustrophobia, excessive body size compromising placement in scanner;
• Corrected visual acuity of less than 20/40 as assessed by the Snellen Visual Acuity chart

Sponsors & Collaborators

• SRI International: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

SRI International

Menlo Park, California, 94025, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Fiona Baker

CONTACT

650 859 3062; fiona.baker@sri.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross-over within-subject, between-group

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: June 9, 2021
• Primary Completion: January 5, 2023
• Study Completion: May 5, 2023
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (1)