Mason 2009.
| Trial name or title | Duloxetine versus pregabalin for alcohol dependence |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 150 participants Inclusion criteria: both genders; 18 years of age and older; meeting DSM‐IV criteria for alcohol dependence and drinking an average of ≥ 21 drinks weekly for males, ≥ 14 for females, with at least one heavy drinking day (≥ five males, ≥ four females) per week; seeking research‐based outpatient treatment for alcohol problems; willing to participate in abstinence‐oriented individual counselling sessions; normal bilirubin, and ALT, AST and GGT values no greater than three times the ULN, with no evidence of hepatic insufficiency; in good physical health; not using any medications, supplements or herbs that could potentially increase risk of hepatotoxicity Exclusion criteria: active suicidal ideation; medical disorders that will increase potential risk or interfere with study participation; sexually active female individuals who are pregnant or nursing or refuse to use a reliable method of birth control; males who refuse to use a reliable method of birth control; meeting DSM‐IV criteria for current anxiety or affective disorders, current or lifetime bipolar disorder, other substance use disorders or any current major Axis I disorder other than alcohol or nicotine dependence; inability to understand and/or comply with the provisions of the protocol and consent form; treatment with an investigational drug during the previous month; prior treatment with pregabalin or duloxetine; treatment with an antidepressant medication; sensitivity to study drugs; ongoing treatment with disulfiram, naltrexone, acamprosate or other medications that may affect study outcomes; ongoing treatment with drugs that may increase potential risk; abstinence longer than one month before randomisation; individuals who require medicated detoxification; individuals for whom treatment of alcoholism is mandated by a legal authority; inability to identify at least one collateral informant to verify drinking status at baseline and monthly during study and to assist in tracking participant for follow‐up assessments |
| Interventions | (1) Duloxetine; (2) pregabalin; (3) placebo Drug dose: duloxetine up to 60 mg/d; pregabalin up to 600 mg/d Behavioural: standardised behavioural therapy Duration: 12 weeks. Country of origin: USA |
| Outcomes | Primary outcomes: drinking quantity and frequency; affective state Secondary outcomes: craving; mood; sleep; adverse events; physiological reactivity |
| Starting date | July 2009 |
| Contact information | Susan B Quello, BA, BS, 858‐784‐7327, squello@scripps.edu; Barbara J. Mason, PhD, The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research, La Jolla, California, United States 92037 |
| Notes |