Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia

NCT03479086 | Unknown Phase 3 DMC

• 1 other identifier: X16-0231
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (5)

• Number of heavy drinking days, as measured by the Time Line Follow Back

  Corroborated with Phosphatidylethanol (PEth) levels

  Over 12 weeks

• Time to relapse, as measured by the Time Line Follow Back

  Corroborated with PEth levels

  Over 12 weeks

• Time to lapse, as measured by the Time Line Follow Back

  Corroborated with PEth levels

  Over 12 weeks

• Number of days abstinent, as measured by the Time Line Follow Back

  Corroborated with PEth levels

  Over 12 weeks

• Number of standard drinks per drinking day, as measured by the Time Line Follow Back

  Corroborated with PEth levels

  12 weeks

Secondary Outcomes (10)

• Self report of adverse events

  12 weeks

• Penn Alcohol Craving Scale for alcohol craving

  12 weeks

• DASS21 score for presence and/or severity of anxiety

  12 weeks

• DASS21 score for presence and/or severity of depression

  12 weeks

• Insomnia Severity Index for sleep disturbances

  12 weeks

Other Outcomes (2)

• The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days

  12 weeks

• Cost-effectiveness of topiramate versus naltrexone, as measured by Disability-Adjusted Life Years (DALYs)

  12 weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate 200mg/day

Drug: Topiramate

Naltrexone

EXPERIMENTAL

Naltrexone 50mg/day

Drug: Naltrexone

Interventions

Topiramate DRUG

200mg/day 100mg b.i.d

Topiramate

Naltrexone DRUG

50mg/day

Naltrexone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders Version V criteria
• Age 18-70
• Average weekly alcohol consumption of \>30 standard drinks for men and \>25 standard drinks for women, with a weekly average of \> 2 heavy drinking days during the month before screening
• Adequate cognition and English language skills to give valid consent and complete research interviews
• Willingness to give written informed consent
• Willingness to provide a blood sample for genotyping
• Written informed consent

You may not qualify if:

• Active major psychological disorder associated with psychosis, significant suicide risk, and signs of impaired cognitive functioning
• Pregnancy or lactation
• Concurrent use of any psychotropic medication other than antidepressants
• Currently taking any tricyclic antidepressant
• Use of antiretroviral dolutegravir
• Any substance dependence other than nicotine
• Opioid abuse, opioid dependence, or on opioid maintenance treatment
• Clinically significant liver disease
• History of nephrolithiasis
• History of glaucoma
• Lack of stable housing and/or contact phone number
• Previous hypersensitivity to TOP or NTX
• Any alcohol pharmacotherapy within the past month

Sponsors & Collaborators

• South West Sydney Local Health District: lead
• National Health and Medical Research Council, Australia: collaborator
• University of Sydney: collaborator

Study Sites (1)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

RECRUITING

Related Publications (2)

• Logge WB, Haber PS, Hurzeler T, Gallagher H, Kranzler H, Morley KC. Neural cue reactivity and intrinsic functional connectivity in individuals with alcohol use disorder following treatment with topiramate or naltrexone. Psychopharmacology (Berl). 2025 Jul;242(7):1641-1652. doi: 10.1007/s00213-025-06745-7. Epub 2025 Jan 24.

  PMID: 39853353 DERIVED

• Morley KC, Kranzler HR, Luquin N, Baillie A, Shanahan M, Trent R, Teesson M, Haber PS. Topiramate versus naltrexone for alcohol use disorder: study protocol for a genotype-stratified, double-blind randomised controlled trial (TOP study). Trials. 2018 Aug 16;19(1):443. doi: 10.1186/s13063-018-2824-z.

  PMID: 30115121 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Paul S Haber, MBBS

  Sydney Local Health District

  PRINCIPAL INVESTIGATOR

• Andrew Baillie, PhD

  Macquarie University

  PRINCIPAL INVESTIGATOR

• Kirsten C Morley, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Morley, PhD

CONTACT

95153636; kirsten.morley@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Clinical Investigator

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 27, 2018
• Study Start: June 20, 2017
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)