A Phase 1 interventional study of Mavoglurant and Placebo in Alcohol Drinking, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
Among 32 studies in Alcohol Drinking by Yale University — 6 open to participants now, 6 under way, none of them phase 3. Alcohol Drinking · Yale University.
Among the 32 studies in Alcohol Drinking by Yale University, this one is the 20th largest by enrollment of the 31 interventional ones, is one of 3 that started in 2018, is one of 13 in phase 1, and was the 17th registered.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 34 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →6 of the 32 studies in Alcohol Drinking by Yale University are open now, in 1 country. Each count lists the studies.
Of the 97 Alcohol Drinking studies recruiting now, 37 (38%) set no upper age limit and 52 (54%) stop at 75 or younger; 10 take children under 18; 47 take healthy volunteers.
This study: 21 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2018.
Median enrollment 57 across the 31 interventional studies, 54 across the 1 observational. Of the 25 that completed or were terminated, 16 (64%) have results posted.
Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
2 of the studies in Alcohol Drinking by Yale University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06513819Yale UniversityHIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention) | 2027-08 |
| NCT06070649Yale UniversityThe Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD) | 2027-08-01 |
Among the 32 studies in Alcohol Drinking by Yale University, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 mg mavoglurant once daily for 7-10 days
Drug: Mavoglurant
Placebo once daily for 7-10 days
Drug: Placebo
200 mg Mavoglurant
Placebo
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
Time frame: Day 10
| Milestone | 200 mg Mavoglurant | Placebo |
|---|---|---|
| Started | 17 | 17 |
| Completed | 10 | 14 |
| Not completed | 7 | 3 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Family/personal issues | 3 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
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
| Participants | 200 mg Mavoglurant | Placebo |
|---|---|---|
| Number of participants that reported Adverse Event(s) | 9 | 8 |
| Abnormal/Clinically Significant lab values after Mavoglurant and alcohol administration | 0 | 0 |
Collected over Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 200 mg Mavoglurant | 0/17 (0%) | 0/17 (0%) | 17/17 (100%) |
| Placebo | 0/17 (0%) | 0/17 (0%) | 8/17 (47.1%) |
| Event | 200 mg Mavoglurant | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 9/17 | 1/17 |
| InsomniaNervous system disorders | 6/17 | 2/17 |
| NauseaGastrointestinal disorders | 6/17 | 4/17 |
| Nervousness / AnxietyPsychiatric disorders | 6/17 | 0/17 |
| HeadacheNervous system disorders | 5/17 | 2/17 |
| Appetite ChangeGastrointestinal disorders | 4/17 | 0/17 |
| Lack of FocusNervous system disorders | 4/17 | 0/17 |
| Mania/HyperactivityPsychiatric disorders | 3/17 | 0/17 |
| FatigueNervous system disorders | 2/17 | 3/17 |
| Feeling High/IntoxicatedPsychiatric disorders | 3/17 | 0/17 |
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).
| Age, Categorical(Participants) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 17 | 33 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| Mean | 26.3 ± 4.51 | 29.1 ± 6.68 | 27.7 ± 5.83 |
| Sex: Female, Male(Participants) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 9 | 10 | 19 |
| Ethnicity (NIH/OMB)(Participants) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| White | 10 | 7 | 17 |
| Asian | 4 | 4 | 8 |
| Black | 1 | 2 | 3 |
| Multi-Race | 1 | 2 | 3 |
| Other | 0 | 2 | 2 |
| Region of Enrollment(participants) | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| United States | 16 | 17 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mavoglurant