Alcohol Use DisorderPhase 1NCT06860607
Environment and Alcohol: A Pilot Study
A Phase 1 study testing Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption in people with Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 1 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To meet eligibility for this study, participants must meet all the following criteria:
- At least 21 years old
- Owns a cellular device ("smart phone") and is willing to download the EMA application and use it to answer the study questionnaires
- Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
- Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of > 7 drinks per week for females or > 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with > 3 drinks for females or > 4 drinks for males during the 28-day period prior to screening
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10
- If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.
Who cannot join
- Any individual who meets any of the following criteria will be excluded from this study:
- Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD
- 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.
- Known history of clinically significant cybersickness.
- Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
- Unable to speak, read, write, and understand English
- Justification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Lorenzo Leggio, M.D., 240-478-1503, lorenzo.leggio@nih.gov
About this study
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.
Read more
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:
- 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.
- 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.
Read the detailed description
Study Description:
This study will investigate the effects of cognitive and sensorimotor environmental enrichment (EE) on alcohol drinking, alcohol cue-reactivity, and other related outcomes in participants with alcohol use disorder (AUD). The hypothesis is that the psychological and physiological effects of environmental enrichment will confer therapeutic benefits for people with AUD, especially on measures of alcohol consumption and cue-elicited craving.
Objectives:
Primary Objectives:
- Evaluate the effects of EE on alcohol consumption
Secondary Objectives:
- Evaluate the effects of EE on other ecological momentary assessments (EMA)
- Evaluate the effects of EE on bar-lab assessments
Endpoints:
Primary Endpoints:
- Self-reported alcohol consumed using ecological momentary assessment
Secondary Endpoints:
- State assessments of varying psychological, social, and environmental domains associated with AUD
- - Cue reactivity: AUQ, AAS
- APT
- Alcohol challenge: B-BAES, DEQ-5, AUQ, BrAC
Pupil diameter
- Conditions
- Alcohol Use Disorder
- Being tested
- Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption
- Keywords
- Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the effects of Environmental Enrichment (EE) on alcohol consumptionBehavioural
This study investigates how different environments and activities affect alcohol consumption and related outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Subject with alcohol use disorder | Other | subjects (Female/ Male) aged 21 and up Receives: Behavioral: Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of EE on alcohol consumption
Self-reported alcohol consumed using ecological momentary assessment
Measured: 1-3 months for each participant
Secondary outcomes (2)
Evaluate the effects of EE on other EMA assessments
Real-time, real-world data collection of state variables and alcohol consumption enhances the ecological validity of the data. This also allows for evaluation of how dynamics in psychological, social and environmental measures are related to changes in alcohol consumption.
Measured: 1-3 months for each participant
Evaluate the effects of EE on bar-lab assessments
Alcohol craving (measure here via AUQ) is a key factor and predictor of persistent and heavy alcohol use and is attenuated by some treatments. AAS measures attention to alcohol cues. APT serves as a measure of economic demand for alcohol. The subjective response to alcohol is a predictor of AUD vulnerability and treatment outcomes.
Measured: 1-3 months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start29 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860607
- Sponsor's protocol ID
- 10002341
- Other IDs
- 002341-DA
- Status last verified
- 19 Oct 2026
- First submitted
- 5 Mar 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koob GF, Volkow ND. Neurobiology of addiction: a neurocircuitry analysis. Lancet Psychiatry. 2016 Aug;3(8):760-773. doi: 10.1016/S2215-0366(16)00104-8.
PubMed 27475769Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022.
PubMed 36089933Nithianantharajah J, Hannan AJ. Enriched environments, experience-dependent plasticity and disorders of the nervous system. Nat Rev Neurosci. 2006 Sep;7(9):697-709. doi: 10.1038/nrn1970.
PubMed 16924259Edwards S, Kenna GA, Swift RM, Leggio L. Current and promising pharmacotherapies, and novel research target areas in the treatment of alcohol dependence: a review. Curr Pharm Des. 2011;17(14):1323-32. doi: 10.2174/138161211796150765.
PubMed 21524263
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environment and Alcohol: A Pilot Study
- ClinicalTrials.gov ID
- NCT06860607
- Acronym / sponsor ID
- 10002341
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Study Description:
This study will investigate the effects of cognitive and sensorimotor environmental enrichment (EE) on alcohol drinking, alcohol cue-reactivity, and other related outcomes in participants with alcohol use disorder (AUD). The hypothesis is that the psychological and physiological effects of environmental enrichment will confer therapeutic benefits for people with AUD, especially on measures of alcohol consumption and cue-elicited craving.
Objectives:
Primary Objectives:
- Evaluate the effects of EE on alcohol consumption
Secondary Objectives:
- Evaluate the effects of EE on other ecological momentary assessments (EMA)
- Evaluate the effects of EE on bar-lab assessments
Endpoints:
Primary Endpoints:
- Self-reported alcohol consumed using ecological momentary assessment
Secondary Endpoints:
- State assessments of varying psychological, social, and environmental domains associated with AUD
- - Cue reactivity: AUQ, AAS
- APT
- Alcohol challenge: B-BAES, DEQ-5, AUQ, BrAC
Pupil diameter
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject with alcohol use disorder | Other | Behavioral: Evaluate the effects of Environmental Enrichment (EE) on alcohol consumptionsubjects (Female/ Male) aged 21 and up |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 21 years old
- Owns a cellular device ("smart phone") and is willing to download the EMA application and use it to answer the study questionnaires
- Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
- Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of > 7 drinks per week for females or > 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with > 3 drinks for females or > 4 drinks for males during the 28-day period prior to screening
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10
Key exclusion criteria (7 listed)
- Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD
- 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.
- Known history of clinically significant cybersickness.
- Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
- Unable to speak, read, write, and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the effects of Environmental Enrichment (EE) on alcohol consumptionThis study investigates how different environments and activities affect alcohol consumption and related outcomes. | Behavioural | Subject with alcohol use disorder |
Primary outcome
Evaluate the effects of EE on alcohol consumption
Time frame: 1-3 months for each participant
Self-reported alcohol consumed using ecological momentary assessment
2 secondary outcomes
Evaluate the effects of EE on other EMA assessments
Time frame: 1-3 months for each participant
Evaluate the effects of EE on bar-lab assessments
Time frame: 1-3 months for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 27475769Koob GF, Volkow ND. Neurobiology of addiction: a neurocircuitry analysis. Lancet Psychiatry. 2016 Aug;3(8):760-773. doi: 10.1016/S2215-0366(16)00104-8.
- Background: PubMed 36089933Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022.
- Background: PubMed 16924259Nithianantharajah J, Hannan AJ. Enriched environments, experience-dependent plasticity and disorders of the nervous system. Nat Rev Neurosci. 2006 Sep;7(9):697-709. doi: 10.1038/nrn1970.
- Background: PubMed 21524263Edwards S, Kenna GA, Swift RM, Leggio L. Current and promising pharmacotherapies, and novel research target areas in the treatment of alcohol dependence: a review. Curr Pharm Des. 2011;17(14):1323-32. doi: 10.2174/138161211796150765.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Leggio, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption in people with Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan E Tyler ((240) 789-0347, ryan.tyler@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effects of EE on alcohol consumption (time frame: 1-3 months for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860607, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.