Alcohol Drinking
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMavoglurant
200 mg Mavoglurant
DRUGPlacebo
Placebo
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ages 21-50 2. Able to read English at 6th grade level or higher and to complete study evaluations 3. Social drinkers 4. Willing to abstain from drinking alcohol during the outpatient study medication treatment period
Exclusion criteria
1. Seeking treatment for alcohol drinking 2. Current DSM-V criteria for any other substances, other than alcohol or nicotine. 3. Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates. 4. Regular use of psychoactive drugs including anxiolytics and antidepressants. 5. Psychotic or otherwise severely psychiatrically disabled. 6. Any medical conditions (including hepatic and renal impairment) that would contraindicate the consumption of alcohol or administration of mavoglurant. 7. History of neurological trauma or disease, delirium, or hallucinations, or any significant systemic illness or unstable medical condition. 8. Women who are pregnant, nursing, or refuse to use a reliable method of birth control. Urine pregnancy tests will be completed at intake and prior to administration of alcohol at each lab session. 9. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the alcohol administration. 10. Subjects who have taken any investigational drug and/or participated in another study which involves additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol within 4 weeks immediately preceding admission to the treatment period. 11. Subjects who report any daily drug use during the 30 days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation. 12. Subjects who have donated blood within the past six weeks. 13. Current use (within 30 days of screening) of specific psychoactive medications (e.g., typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc 14. Current use of warfarin. 15. Use of any medications that are contraindicated with mavoglurant and alcohol. 16. AST, ALT, total bilirubin \>1.5 times upper normal; serum creatinine, \>2 times upper normal limit, total bilirubin\>1.5 times ULN; Serum creatinine \>2.0 times ULN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal Labs and Adverse Events | Day 10 | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 200 mg Mavoglurant 200 mg mavoglurant once daily for 7-10 days
Mavoglurant: 200 mg Mavoglurant | 16 |
| Placebo Placebo once daily for 7-10 days
Placebo: Placebo | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Family/Personal issues | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | 200 mg Mavoglurant | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Continuous | 26.3 years STANDARD_DEVIATION 4.51 | 29.1 years STANDARD_DEVIATION 6.68 | 27.7 years STANDARD_DEVIATION 5.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Multi-Race | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 7 Participants | 17 Participants |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 17 / 17 | 8 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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
Time frame: Day 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 200 mg Mavoglurant | Abnormal Labs and Adverse Events | Number of participants that reported Adverse Event(s) | 9 Participants |
| 200 mg Mavoglurant | Abnormal Labs and Adverse Events | Abnormal/Clinically Significant lab values after Mavoglurant and alcohol administration | 0 Participants |
| Placebo | Abnormal Labs and Adverse Events | Number of participants that reported Adverse Event(s) | 8 Participants |
| Placebo | Abnormal Labs and Adverse Events | Abnormal/Clinically Significant lab values after Mavoglurant and alcohol administration | 0 Participants |