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. 2014 Nov 29;50(1):24–29. doi: 10.1093/alcalc/agu085

Table 1.

Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria

  • Diagnosis of alcohol dependence according to DSM-IV;

  • Age range 18–60 years (inclusive);

  • Alcohol intake of at least 2 HDDa per week on average and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women in the 4 weeks before enrolment;

  • Ability to understand and sign written informed consent;

  • Ability to refrain from drinking for at least 3 days prior to randomization day;

  • Desire to achieve abstinence or to greatly reduce alcohol consumption;

  • Evidence of a stable residence;

  • Presence of a referred family able to assist with drug administration and monitoring.

  • Clinically significant medical disease that might interfere with the evaluation of the study medication or that might represent a safety concern;

  • Clinical significant psychiatric illness including any psychotic disorders, bipolar disorder, severe depression, suicidal ideation, substance use disorders other than alcohol and nicotine dependence or cannabis abuseb;

  • Abstinence from alcohol for >10 days prior to randomization day;

  • Concurrent use of psychotropic medication including anti-depressants, mood stabilizers, antipsychotics, anxiolytics or hypnotics;

  • Concurrent use of anticonvulsants, insulin, oral hypoglycemics or any medication that may interact with baclofen;

  • AST and/or ALT levels >3 times of UNL, or bilirubin and/or creatinine greater than UNL;

  • Urine drug screen positive for substance of abuse other than cannabis;

  • Pregnant women and women of childbearing potential who did not practice a medically acceptable form of birth control;

  • Breastfeeding women;

  • Individuals requiring inpatient treatment or more intense outpatient treatment for AD;

  • Participation in any clinical trial within the last 60 days;

  • Court-mandated participation in alcohol treatment or pending incarceration.

DSM IV, Diagnostic and Statistical Manual of Mental Disorders; HDD, heavy drinking days; AST, aspartate aminotransferase; ALT, alanine aminotransferase; UNL, upper normal limit; AD, alcohol dependence.

aHDD is an overall intake of five or more drinks per day for men and of four or more drinks per day for women.

bWhile cannabis use was not an exclusion criterion, none of the included subjects tested positive for marijuana.