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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50AA012870-21 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers.
The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers.
Subjects will participate in two lab sessions, one prior to taking medication and one following 7-10 days of mavoglurant/placebo. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak BAC the investigators have observed in prior research studies. Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg Mavoglurant | Experimental | 200 mg mavoglurant once daily for 7-10 days |
|
| Placebo | Placebo Comparator | Placebo once daily for 7-10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavoglurant | Drug | 200 mg Mavoglurant |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Labs and Adverse Events | Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant | Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, PhD | Professor of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC, Substance Abuse Center | New Haven | Connecticut | 06519 | United States |
34 Participants enrolled in the study, however there was an error in calculating alcohol dose in one participant. Analysis excluded this one participant, 33 analyzed at baseline.
24 completed study and had outcome data, excluding this 1 participant, the final analysis is n=23.
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg Mavoglurant | 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant |
| FG001 | Placebo | Placebo once daily for 7-10 days Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 participant from the Mavoglurant condition was not included in the analysis due to an error in calculating alcohol dose (17 were randomized into that condition, 16 were analyzed).
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Mavoglurant | 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant |
| BG001 | Placebo | Placebo once daily for 7-10 days Placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abnormal Labs and Adverse Events | Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant | 34 Participants enrolled in the study, however there was an error in calculating alcohol dose in one participant. Analysis excluded this one participant, 33 analyzed at baseline. 24 completed study and had outcome data, excluding this 1 participant, the final analysis is n=23. | Posted | Count of Participants | Participants | Day 10 |
|
Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks.
Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 mg Mavoglurant | 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Racing Heart | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suchitra Krishnan-Sarin | Yale University | 203-974-7595 | suchitra.krishnan-sarin@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2023 | Jul 10, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2023 | Mar 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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| Drug |
Placebo |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
Placebo once daily for 7-10 days Placebo: Placebo |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | Placebo | Placebo once daily for 7-10 days Placebo: Placebo | 0 | 17 | 0 | 17 | 8 | 17 |
| Mania/Hyperactivity | Psychiatric disorders | Non-systematic Assessment |
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| Dissociation | Nervous system disorders | Non-systematic Assessment |
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| Appetite Change | Gastrointestinal disorders | Systematic Assessment |
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| Acid Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sore Arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | From IV placement during study lab session |
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| Back Ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Confusion | Nervous system disorders | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Extra sense of focus | Nervous system disorders | Systematic Assessment |
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| Face Numbness | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
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| Feeling High/Intoxicated | Psychiatric disorders | Systematic Assessment |
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| Frequent Urination | Renal and urinary disorders | Systematic Assessment |
|
| Good Mood / Awake | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hurt Ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
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| Irritable | Psychiatric disorders | Non-systematic Assessment |
|
| Itchy | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lack of Focus | Nervous system disorders | Non-systematic Assessment |
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| Memory Loss | Nervous system disorders | Systematic Assessment |
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| Mood Altered | Psychiatric disorders | Non-systematic Assessment |
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| Mouth and Throat Pain | General disorders | Non-systematic Assessment |
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| Moving/Walking Slower | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Twitch | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nervousness / Anxiety | Psychiatric disorders | Systematic Assessment |
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| Night Sweats | Nervous system disorders | Non-systematic Assessment |
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| Nightmares | Psychiatric disorders | Non-systematic Assessment |
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| Pimples/Face Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sad | Psychiatric disorders | Non-systematic Assessment |
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| Social Anxiety | Social circumstances | Non-systematic Assessment |
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| Strange Feeling Behind the Eyes | Eye disorders | Non-systematic Assessment |
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| Vision Felt Slower | Eye disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Warm Feeling in Heart; the Feeling of God | General disorders | Non-systematic Assessment |
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| Lightheaded | Nervous system disorders | Systematic Assessment |
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| Saw Scary Faces While Sleeping | Nervous system disorders | Non-systematic Assessment |
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| Sinus Pressure | General disorders | Non-systematic Assessment |
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| Closer things looked closer; Farther things looked farther away | Eye disorders | Systematic Assessment |
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| Hazy Vision | Eye disorders | Systematic Assessment |
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| Trailing Vision | Eye disorders | Systematic Assessment |
|
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