An interventional study of Levetiracetam (Keppra) and Placebo in Alcohol Abuse and Drug Abuse, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.
The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users who are social drinkers.
The specific aims are to:
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 46 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.
Drug: Levetiracetam (Keppra) · Drug: Placebo
Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Drug: Levetiracetam (Keppra) · Drug: Placebo
Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days. Group B: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Also known as: Keppra
Standard Alcoholic Drinks Per Treatment Period
The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.
Time frame: During each 14 day treatment period
Recruitment was conducted online (Craigslist) and from publicly posted flyers.
| Milestone | Group A: Crossover Between Low Dose Keppra and Placebo | Group B: Crossover Between High Dose Keppra and Placebo |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.
| number of drinks per treatment period | All Subjects (n = 46) Placebo | All Subjects (n = 46) Levetiracetam |
|---|---|---|
| Standard Alcoholic Drinks Per Treatment Period | 41.2 ± 2.8 | 45.4 ± 3.6 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects (n = 46) Placebo | — | 0/46 (0%) | 0/46 (0%) |
| All Subjects (n = 46) Levetiracetam | — | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Group A: Crossover Between Low Dose Keppra and Placebo | Group B: Crossover Between High Dose Keppra and Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 23 | 46 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group A: Crossover Between Low Dose Keppra and Placebo | Group B: Crossover Between High Dose Keppra and Placebo | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 11 | 11 | 22 |
| Region of Enrollment(participants) | Group A: Crossover Between Low Dose Keppra and Placebo | Group B: Crossover Between High Dose Keppra and Placebo | Total |
|---|---|---|---|
| United States | 23 | 23 | 46 |
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco