Mavoglurant in Alcohol Drinking

NCT ID: NCT03327792

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2023-07-13

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.

Conditions

Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

200 mg Mavoglurant

200 mg mavoglurant once daily for 7-10 days

Group Type: EXPERIMENTAL

Mavoglurant

Intervention Type: DRUG

200 mg Mavoglurant

Placebo

Placebo once daily for 7-10 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Mavoglurant

200 mg Mavoglurant

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Suchitra Krishnan-Sarin

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suchitra Krishnan-Sarin, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Psychiatry

Locations

CMHC, Substance Abuse Center

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2P50AA012870-21

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000021703

Identifier Type: -

Identifier Source: org_study_id