Environmental Enrichment for Alcoholism

Overseen by Lorenzo Leggio, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: AUD medications

Disqualifiers: Unstable conditions, Cybersickness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Alcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes. Objective: To evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD. Eligibility: People aged 21 years and older with AUD. Design: Participants will have up to 10 study visits in Baltimore. Participants will have a baseline visit. They will have a physical exam with blood and urine tests. They will have a breath test for alcohol and a test that measures body composition. They will answer questions about their alcohol and substance use; mental and physical health; mood and anxiety; and sleep quality. Participants will download an app called MetricWire. The app will send 3 sets of questions to be answered at different times throughout the day. The study visits will include 2 stages: 1. Active stage. On these visits, participants will use a virtual reality system called the Meta Quest Pro (MQP) as they choose. Then they may choose among video games, puzzles, books, crafts, and other activities.. These sessions will last for 3 hours. 2. Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours. On the last visit of each stage, participants will sit in a room that looks like a bar. They will answer questions about their cravings, their urge to drink, and how many drinks they would buy. Participants will be served 1 drink containing alcohol. They will be asked about their cravings and subjective effects of alcohol after drinking it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using FDA-approved medications for alcohol use disorder (AUD) or seeking treatment for AUD.

What data supports the effectiveness of the treatment Environmental Enrichment for alcoholism?

Research in animal models shows that environmental enrichment can reduce the risk of relapse in alcohol-seeking behavior after a period of abstinence. Additionally, studies suggest that environmental enrichment may help prevent relapse and reduce compulsive drug-taking behaviors in substance use disorders. ^{1 2 3 4 5}

Is environmental enrichment safe for humans?

Environmental enrichment has been studied mostly in animals, where it shows potential benefits for reducing relapse in substance use disorders. While there is limited direct safety data for humans, the components of environmental enrichment, such as physical activity and social interaction, are generally considered safe. ^{1 2 3 5 6}

How does environmental enrichment treatment differ from other treatments for alcoholism?

Environmental enrichment is unique because it involves enhancing the living environment with activities like physical exercise, social interaction, and cognitive challenges, which can reduce the risk of relapse in alcohol use disorder. Unlike traditional treatments that may focus on medication or therapy alone, this approach aims to change behavior by providing a stimulating and supportive environment. ^{1 2 3 5 7}

Research Team

Lorenzo Leggio, M.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

This study is for adults over 21 with Alcohol Use Disorder (AUD). It's designed to see if different activities and environments can influence their drinking habits and mental health. Participants must be able to visit Baltimore up to 10 times.

Inclusion Criteria

I am at least 21 years old.

I own a smartphone and agree to use an app for study questionnaires.

Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10

Exclusion Criteria

I am currently using or seeking treatment for alcohol use disorder.

Known history of clinically significant cybersickness

Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a physical exam, blood and urine tests, a breath test for alcohol, and a body composition test. They answer questions about alcohol and substance use, mental and physical health, mood and anxiety, and sleep quality.

1 visit

1 visit (in-person)

Active Stage

Participants use a virtual reality system and engage in activities like video games, puzzles, books, and crafts. Sessions last for 3 hours.

1-3 months

Multiple visits (in-person)

Passive Stage

Participants watch videos selected by the research team. Sessions last for 3 hours.

1-3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of alcohol consumption and cue reactivity.

4 weeks

Treatment Details

Interventions

• Environmental Enrichment (Behavioural Intervention)

Trial Overview The trial tests the impact of Environmental Enrichment (EE) on alcohol consumption in AUD patients using a virtual reality system, various leisure activities, and video watching sessions. The study involves physical exams, questionnaires, an app for daily questions, and simulated bar environments.

Participant Groups

Group I: Subject with alcohol use disorder Experimental Treatment 1 Intervention

subjects (Female/ Male) aged 21 and up

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Findings from Research

A randomized controlled trial involving 135 participants with severe alcohol use disorder (AUD) will assess the effectiveness of a new environmental enrichment (EE) protocol, which includes mindfulness in virtual reality and physical activity, in reducing relapse rates after treatment.

The study aims to show that participants receiving the EE intervention will have a lower relapse rate at 2 weeks post-treatment compared to a control group receiving standard AUD management, with additional assessments of craving and mindfulness skills over 1 and 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial. Barillot, L., Chauvet, C., Besnier, M., et al.[2023]

Environmental enrichment (EE) shows promise as a therapeutic strategy for treating substance use disorders, as it has been shown to reduce compulsive drug-taking and prevent relapse in animal models.

Clinical evidence suggests that multidimensional EE interventions, which include physical activity and social interaction, may have similar beneficial effects on reducing cravings and promoting long-term recovery in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of environmental enrichment for substance use disorders. Galaj, E., Barrera, ED., Ranaldi, R.[2021]

Environmental enrichment (EE) significantly enhanced the acquisition of schedule-induced drinking (SID) behavior in 24 male Wistar rats, with the EE group exhibiting faster development and higher drinking levels compared to the isolated group.

The results suggest that EE may promote SID through positive reinforcement rather than stress reduction, challenging previous assumptions about the relationship between environmental conditions and schedule-induced behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental enrichment accelerates the acquisition of schedule-induced drinking in rats. Fuentes-Verdugo, E., López-Tolsa, GE., Pascual, R., et al.[2023]

Environmental enrichment increased ethanol intake specifically in female rats, suggesting that enhanced exploration of new environments may lead to higher alcohol consumption in this group.

The study indicates that while environmental enrichment can promote exploratory behavior, it may also inadvertently increase the risk of ethanol intake, particularly in females, highlighting the need for caution in clinical programs aimed at treating alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental enrichment during adolescence heightens ethanol intake in female, but not male, adolescent rats that are selectively bred for high and low ethanol intake during adolescence. Suárez, A., Fabio, MC., Bellia, F., et al.[2021]

Male weanling rats raised in an enriched environment for 90 days consumed significantly more ethanol compared to those raised in isolation or those switched to isolation after enrichment.

Transitioning rats from an enriched environment to isolation led to a notable decrease in their voluntary ethanol intake, suggesting that continued exposure to an enriched environment is crucial for increased alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of environmental enrichment on voluntary ethanol intake in rats. Rockman, GE., Gibson, JE., Benarroch, A.[2019]

Exposure to environmental enrichment (EE) during abstinence from methamphetamine significantly reduced drug-seeking behavior in rats, suggesting a potential preventive strategy against relapse.

The reduction in drug-seeking was associated with decreased levels of glucocorticoid receptors (GR) in the hippocampus, indicating that EE may help restore the brain's stress response system disrupted by methamphetamine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of relapse to methamphetamine self-administration by environmental enrichment: involvement of glucocorticoid receptors. Nicolas, C., Hofford, RS., Dugast, E., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of environmental enrichment for substance use disorders. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Environmental enrichment reduces the propensity to relapse following punishment-imposed abstinence of alcohol seeking. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Environmental enrichment accelerates the acquisition of schedule-induced drinking in rats. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Environmental enrichment during adolescence heightens ethanol intake in female, but not male, adolescent rats that are selectively bred for high and low ethanol intake during adolescence. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of environmental enrichment on voluntary ethanol intake in rats. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Prevention of relapse to methamphetamine self-administration by environmental enrichment: involvement of glucocorticoid receptors. [2022]