Matching Genotypes and Serotonergic Medications for Alcoholism
Alcoholism
About this trial
This is an interventional diagnostic trial for Alcoholism focused on measuring ondansetron, sertraline, lab studies, alcoholism, alcohol dependence
Eligibility Criteria
Inclusion Criteria:
- Must be between 21 and 65 years old (inclusive).
- Participants may be male or female and must be in good health as confirmed by medical history, baseline physical examination, ECG, laboratory tests, urinalysis and vital signs.
Female participants must be:
Postmenopausal for at least one year, surgically sterile, or Practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at baseline screening and prior to the alcohol challenge sessions.
- Participants must understand that this is not a treatment study.
- A diagnosis of Alcohol dependence using Module E of the structured clinical interview for the DSM-IV (SCID). Alcohol dependent as defined by an AUDIT score ≥ 12 and men must consume ≥ 35 and women ≥ 28 standardized alcoholic beverages a week.
- Participants must be willing to take oral medication, adhere to the medication regimen and be willing to return for weekly visits and the alcohol challenge sessions.
- Participants must be able to read and comprehend written instructions and comprehend and complete all scale and inventories required by the protocol.
- Participants must have signed an informed consent indicating they understand the purpose of and procedures required for the study and willingness to participate.
Exclusion Criteria:
- Pregnancy or breast feeding women.
- Positive urine drug screen at baseline for any illegal substance other than marijuana.
- Participants will be excluded if they have: (a) clinically significant medical abnormalities (i.e. ECG, hematological assessment, bilirubin > 150% of the upper limit of normal or ALT or AST elevations >300% the upper limit of normal, biochemistry including urinalysis, electrolytes,). (Persons with medical conditions that are adequately controlled by their primary care physician will not be excluded.)
- Current use of psychotropic medications that cannot be discontinued
- Medical contraindications for use of sertraline or ondansetron
- Taking drugs that interfere with the metabolism of either drug that cannot be stopped per study physician.
- Allergic to sertraline or ondansetron
- Must have a breath alcohol concentration (BrAC) = 0.000 at the beginning of the alcohol challenge sessions.
- Creatinine clearance ≤ 60 dl/min.
- Individuals with a reasonable expectation of being institutionalized during the course of the trial or pending legal charges.
- Participants who have significant alcohol withdrawal symptoms (clinical institute withdrawal assessment for alcohol revised (CIWA-Ar) >10.
- lifetime depression or a history of suicide
- history of seizures (e.g. epilepsy) or migraine headaches -
Sites / Locations
- Center for Alcohol and Addiction Studies
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Ondansetron, Placebo, Sertraline
Sertraline, Placebo, Ondansetron
LL-carriers receiving ondansetron compared to either placebo or sertraline, will result in a significant reduction in alcohol consumption.
SL and SS-carriers receiving sertraline compared to either placebo or ondansetron, will result in a significant reduction in alcohol consumption.