Ait‐Daoud 2010.
| Trial name or title | New pharmacotherapy for alcohol and co‐morbid disorders |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 294 participants Inclusion criteria: over the age of 18; DSM‐IV diagnosis of alcohol and nicotine dependence; stable residence; negative pregnancy test at intake and using an acceptable form of contraception; literate in English and able to follow instructions and make use of behavioural treatments; expressing a wish to stop drinking; willing to participate in a treatment programme for nicotine dependence Exclusion criteria: current Axis I DSM‐IV psychiatric disorder that warrants treatment or would preclude safe participation in the protocol; other neurological or psychiatric disorders, such as dependence on any substances except nicotine, caffeine and marijuana; seizure disorders or epilepsy; history of suicide attempts and/or current suicidal ideation/plan as assessed by SCID; serious medical illnesses; severe or adverse reactions to medications (including topiramate); currently receiving active treatment with topiramate; receipt of a drug with known potential for toxicity to a major organ system; female participants pregnant, lactating or not adhering to an acceptable form of contraception; concomitant pharmacotherapy with psychotropics; current use of nicotine replacement treatment or participation in any other treatment for nicotine dependence; clinically significant haematological or biochemical test results requiring urgent treatment; electroconvulsive therapy within the three months preceding screening; members of the same household |
| Interventions | (1) Topiramate high dose, 98 participants; (2) topiramate low dose, 98 participants; placebo, 90 participants Drug dose: topiramate high dose, up to 250 mg/d; topiramate low dose, up to 125 mg/d Alcohol‐dependent smokers will receive brief behavioural compliance enhancement treatment (BBCET) plus a smoking self help manual as their psychosocial treatment Duration: 18 weeks. Country of origin: USA |
| Outcomes | Primary outcomes: percentage of heavy drinking days (TLFB method of measuring alcohol consumption will be used); continuous abstinence rate for smoking (determined by a combination of self report and CO monitoring after the quit date) Secondary outcomes: quality of life (assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire); craving for alcohol and nicotine (using craving scales) |
| Starting date | September 2010 |
| Contact information | Ann Richards, BS, 434 243 0570, AER7G@virginia.edu; Eva Jenkins‐Mendoza, BS, 434 243 0549, EMJ9C@virginia.edu, University of Virginia Center for Addiction Research & Education, Charlottesville, Virginia, United States 22911 |
| Notes |