A Pilot Study on the Safety and Efficacy of Mavoglurant in Alcohol Drinking

2000021703

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.

2018-02-07

2023-07-13

2023-07-13

Completed

Early phase I

34

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2024-03-29