Likhitsathian 2013.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Country: Thailand Setting: residential treatment center Eligibility criteria: included were individuals 18 ‐ 60 years of age with alcohol dependence and more than 1 week of 35 or more standard drinks (men) or 28 or more standard drinks (women) in the four weeks prior to admission, an AUDIT score of 8 or greater, mild or no alcohol withdrawal, likely to be discharged within 14 days, BMI at least 18 kg/m2, and an intention to decrease or stop drinking. Excluded were individuals with previous or current cognitive disorder, schizophrenia and other psychotic disorders, bipolar disorder, antisocial personality disorder, or other substance dependence (besides nicotine and caffeine) during the six months prior to enrollment. Excluded were also individuals who were being treated with antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorothiazide, metformin, pioglitazone, disulfiram, at risk of suicide during the four weeks prior to enrollment, having a physical illness including narrow angle glaucoma, renal impairment, and epilepsy, unstable medical conditions, pregnant or breastfeeding, or receiving medication for fourteen days or longer while in inpatient service. Duration of follow‐up: 12 weeks Informed consent: all participants provided informed consent Ethical approvals: Ethics Committee for Human Research/Institutional Review Board at each site approved the study |
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| Participants |
Sample size: 106 (53 topiramate, 53 placebo) Description of the target population: patients in residential treatment for alcohol dependence Age: 41.5 years (SD = 8.9) Sex: 100% male Race/Ethnicity: not reported Marital status: 47.2% married Harmful alcohol use (baseline): mean drinks per day: 15.4 (SD = 11.8) Co‐occurring disorders: major depression (3.8%) |
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| Interventions |
Type: Pharmacologic + Non‐pharmacologic Description: topiramate and residential treatment involving detoxification, motivational enhancement therapy, and family counseling Duration and frequency: 50 mg capsule of topiramate titrated on a dose escalation to 100mg by week 3 followed by adjustments between 100‐300 mg until week 12 and then tapered from weeks 12‐14. 3‐5 sessions of counseling Delivery and provider: trained psychologist, mental health nurses, physicians Comparison group: placebo and residential treatment involving detoxification, motivational enhancement therapy, and family counseling |
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| Outcomes |
Primary outcome(s): heavy drinking Primary outcome measurement tool(s): Timeline followback Secondary outcome(s): alcohol craving, relapse, drinking days, drinks per day, drinks per drinking day, GGT, health‐related quality of life, side effects Secondary outcome measurement tool(s): Timeline followback, Craving Likert scale, GGT biomarker, Medical Outcomes Study Short Form 36, Side effects Likert scale Time points: 0, 4, 8 and 12‐weeks |
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| Notes |
Study funding and conflicts of interest: Integrated Management of Alcohol Intervention Program (I‐MAP), ThaiHealth Promotion Foundation Linked study records: None |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was balanced using permuted blocks of six. Random allocation sequences were generated by the computer." Pg. 441 |
| Allocation concealment (selection bias) | Low risk | Quote: "A random number indicating intervention or control treatment was kept in an opaque and sealed envelope. The envelope was opened after the baseline assessment" Pg. 441 |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The participants, care providers, and those assessing outcomes were blinded to the assigned treatment" Pg. 441 |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The participants, care providers, and those assessing outcomes were blinded to the assigned treatment" Pg. 441 |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "number of dropouts was high in both groups" Pg. 445 |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |