Baltieri 2008.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Country: Brazil Setting:outpatient alcohol treatment center Eligibility criteria: included were males age 18‐60 years with a diagnosis of alcohol dependence, a history of problems associated with alcohol misuse for two or more years, and admitted to an outpatient treatment center for alcohol use disorder. Excluded were individuals with serious clinical co‐occurring diseases, previous treatment with naltrexone or topiramate within 6 months of randomization, other drug dependence (excluding nicotine), co‐occurring psychiatric disorders that may require pharmacological treatment, inability to provide informed consent, and history of developmental disorders. Duration of follow‐up: 3‐months Informed consent: all participants provided written informed consent Ethical approvals: approved by the Ethics Committee of the Clinical Hospital of the University of Sao Paulo, Brazil |
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| Participants |
Sample size: 155 (52 topiramate, 49 naltrexone, 54 placebo) Description of the target population: Males in outpatient treatment for alcohol use disorder Age: 44.3 years (SD=8.4) Sex: 100% male Race/Ethnicity: 71.0% White, 7.1% Black, 21.9% Mixed race Marital status: 51.6% Married, 16.8% Single, 31.6% Separated/Widowed Harmful alcohol use (baseline): Average quantity of alcohol used per day was 301g (SD=174) and mean dependence scores indicated moderate to severe alcohol dependence (SAD=29, SD=8.5). Co‐occurring disorders: Average depression scores (HAM‐D) indicated mild depression |
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| Interventions |
Type: Pharmacologic + non‐pharmacologic Description: A) Naltrexone, standard cognitive behavioral therapy, relapse prevention, encouragement to attend Alcoholics Anonymous, and 1 week of detoxification prior to initiating naltrexone; B) Topiramate, standard cognitive behavioral therapy, relapse prevention, encouragement to attend Alcoholics Anonymous, and 1 week of detoxification prior to initiating topiramate Duration and frequency: A) 50 mg/day naltrexone + 1 placebo capsule per day; B) Up to 200 mg/day (escalated dose) of topiramate twice per day Delivery and provider: medications provided to participants weekly at which time they also received standard non‐pharmacologic treatment for 12 weeks Comparison group: 2 placebo capsules per day, standard cognitive behavioral therapy, relapse prevention, encouragement to attend Alcoholics Anonymous, 1 week of detoxification prior to initiating placebo |
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| Outcomes |
Primary outcome(s): alcohol consumption Primary outcome measurement tool(s): self‐reported quantity and frequency of alcohol consumption Secondary outcome(s): relapse, abstinence, heavy drinking, side effects, retention Secondary outcome measurement tool(s): Self‐reported alcohol consumption, self‐reported side effects Time points: 1, 2, 3, 4, 6, 8, 10, and 12‐weeks |
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| Notes |
Study funding and conflicts of interest: Fundacao de Amparo a Pesquisa do Estado de Sao Paulo/The State of Sao Paulo Research Foundation Linked study records: Baltieri 2009 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Following the 1‐week detoxification period, the patients were assigned randomly to one of the three medication conditions through a random number list." Pg. 2037 |
| Allocation concealment (selection bias) | Low risk | Quote: "Once a week, they received an envelope with two packages of seven capsules." Pg. 2037 "The packages containing the capsules were delivered by two blinded research assistants who also assessed patient outcomes throughout the study." Pg. 2038 |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "At each appointment, all patients received standardized brief cognitive behavioural interventions from their doctors who were blind to medication conditions." Pg. 2038 |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The packages containing the capsules were delivered by two blinded research assistants who also assessed patient outcomes throughout the study." Pg. 2038 |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "Differences between conditions in overall dropout rates approached significance and were statistically significant within the lost‐to‐follow‐up category with a significant difference between topiramate and placebo in post‐hoc analysis." Pg. 2039 |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |