A Phase 3 interventional study of Topiramate and Naltrexone in Alcohol Dependence, sponsored by South West Sydney Local Health District. Status unknown at 1 site in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-11.
Sponsored by South West Sydney Local Health District · Phase 3, Interventional, and Treatment
Among 26 studies testing topiramate in Alcoholism — 1 open to participants now, 1 under way, none of them phase 3. Topiramate · Alcoholism.
Among the 26 studies testing topiramate in Alcoholism, this one is the 5th largest by planned enrollment, is one of 4 that started in 2017, is one of 4 in phase 3, and was the 25th registered.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 180 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →1 of the 26 studies testing topiramate in Alcoholism is open now, in 1 country. Each count lists the studies.
Topiramate: first FDA approval 1996 (TOPAMAX). What it is approved for, and how studies give it, is on its page →
Of the 239 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 133 (56%) stop at 75 or younger; 11 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2017.
Median enrollment 85 across the 26 interventional studies. Of the 19 that completed or were terminated, 14 (74%) have results posted.
1 of 26 have an industry lead sponsor. The 10 most frequent:
South West Sydney Local Health District is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
South West Sydney Local Health District has 8 studies filed under Alcoholism — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 26 studies testing topiramate in Alcoholism, from their registry updates:
Nothing recorded among them since 2026-09-25.
To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.
Clinicians urgently require new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response.
Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.
Members of our research team have recently demonstrated findings that support the use of topiramate (TOP) 200 mg/day to reduce heavy drinking and pharmacogenetic findings that implicate the GluK1 receptor subunit in the mechanism of these effects.
This project will evaluate the clinical effectiveness and tolerability of topiramate relative to the active control naltrexone (NTX) in heavy drinkers.
Investigators hypothesise that topiramate treated patients will be better able to achieve a reduction in heavy drinking and predict that, based on prior research, that the effects would be moderated by a single nucleotide polymorphism (rs2832407) in GRIK1.
Research personnel will utilise an innovative prospective pharmacogenetic randomisation approach to a double-blind, randomised, controlled trial.
Individuals will receive 12 weeks of titrated treatment with topiramate (200 mg/day) or naltrexone (50mg/day) and medical management.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topiramate 200mg/day
Drug: Topiramate
Naltrexone 50mg/day
Drug: Naltrexone
200mg/day 100mg b.i.d
50mg/day
Number of heavy drinking days, as measured by the Time Line Follow Back
Corroborated with Phosphatidylethanol (PEth) levels
Time frame: Over 12 weeks
Time to relapse, as measured by the Time Line Follow Back
Corroborated with PEth levels
Time frame: Over 12 weeks
Time to lapse, as measured by the Time Line Follow Back
Corroborated with PEth levels
Time frame: Over 12 weeks
Number of days abstinent, as measured by the Time Line Follow Back
Corroborated with PEth levels
Time frame: Over 12 weeks
Number of standard drinks per drinking day, as measured by the Time Line Follow Back
Corroborated with PEth levels
Time frame: 12 weeks
Self report of adverse events
as reported by patient during weekly medical management sessions facilitated by the treating doctor.
Time frame: 12 weeks
Penn Alcohol Craving Scale for alcohol craving
as measured by amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol.
Time frame: 12 weeks
DASS21 score for presence and/or severity of anxiety
as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
Time frame: 12 weeks
DASS21 score for presence and/or severity of depression
as measured by cumulative score for depression related questions
Time frame: 12 weeks
Insomnia Severity Index for sleep disturbances
as measured by cumulative score of satisfaction with current sleep patterns and extent to which sleep disturbances interfere and impair with every day activities and daily functioning
Time frame: 12 weeks
Blood glucose test for diabetes
as measured by fasting blood glucose levels in blood
Time frame: 12 weeks
Liver function tests for clinical markers of liver injury
as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
Time frame: 12 weeks
Body Mass Index
as measured by weight in kilograms (kg) and height in metres (m). These two measurements will be combined together to report BMI in kg/m\^2.
Time frame: 12 weeks
Number of cigarettes smoked daily, as measured by Time Line Follow Back
Time frame: 12 weeks
Self report of daily measures of expectancies, confidence and drinking
as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
Time frame: 12 weeks
The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days
Time frame: 12 weeks
Cost-effectiveness of topiramate versus naltrexone, as measured by Disability-Adjusted Life Years (DALYs)
Time frame: 12 weeks
Plan to share: Yes
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Topiramate · Naltrexone
South West Sydney Local Health District