Johnson 2007 b.
| Trial name or title | Novel pharmacotherapy for dual dependence |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 180 participants Inclusion criteria: both genders; 18 years and older; meeting at least three of the DSM‐IV diagnostic criteria for alcohol and cocaine dependence; expressing a desire for treatment; literacy in English and able to follow study rules, instruction and treatment; reporting cocaine use of at least once per month and alcohol consumption of ≥ 21 drinks/wk and ≥ 14 drinks/wk for men and women, respectively, during the past 30 days; showing at least one positive urine drug screen for cocaine at screen or baseline before randomisation Exclusion criteria: individuals likely to require hospitalisation for severe medical complications or surgery, or those whose severity of illness precludes utilisation of behavioural treatments; women pregnant, breast‐feeding or unwilling to use effective birth control; physical or psychiatric conditions; dependence, defined by DSM‐IV criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine or marijuana or physiological dependence on alcohol requiring medical detoxification; mandated by court to obtain treatment for alcohol and/or cocaine dependence; elevation of liver enzymes (AST, ALT), blood urea nitrogen (BUN) or lactate dehydrogenase (LDH) greater than four times upper limit of the normal range or elevated direct bilirubin; not expected to complete the study protocol because of probable incarceration or relocation from the clinic area; severe or life‐threatening adverse reactions to topiramate in the past or during this clinical trial; AIDS or HIV with CD4 positive T cell counts < 500 mm3; receiving pharmacotherapy for treatment of AIDS or HIV; active syphilis that has not been treated; currently receiving active treatment with topiramate |
| Interventions | (1) Topiramate; (2) placebo Dose: topiramate up to 300 mg/d Participants will be offered weekly cognitive‐behavioural therapy Duration: 12 weeks. Country of origin: USA |
| Outcomes | Primary outcomes: weekly mean proportion of cocaine‐free days and self reported drinking Secondary outcomes: psychosocial functioning as exemplified by improved general well‐being, social functioning and quality of life |
| Starting date | March 2007 |
| Contact information | Mindy Borszich, BA, 1‐888‐882‐2345, uvacare@virginia.edu; University of Virginia Center for Addiction Research and Education, Charlottesville, Virginia, United States 22911 |
| Notes |