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Trial · NCT03479086

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of heavy drinking days, as measured by the Time Line Follow BackOver 12 weeksCorroborated with Phosphatidylethanol (PEth) levels
PrimaryTime to relapse, as measured by the Time Line Follow BackOver 12 weeksCorroborated with PEth levels
PrimaryTime to lapse, as measured by the Time Line Follow BackOver 12 weeksCorroborated with PEth levels
PrimaryNumber of days abstinent, as measured by the Time Line Follow BackOver 12 weeksCorroborated with PEth levels
PrimaryNumber of standard drinks per drinking day, as measured by the Time Line Follow Back12 weeksCorroborated with PEth levels
SecondarySelf report of adverse events12 weeksas reported by patient during weekly medical management sessions facilitated by the treating doctor.
SecondaryPenn Alcohol Craving Scale for alcohol craving12 weeksas 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.
SecondaryDASS21 score for presence and/or severity of anxiety12 weeksas measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
SecondaryDASS21 score for presence and/or severity of depression12 weeksas measured by cumulative score for depression related questions
SecondaryInsomnia Severity Index for sleep disturbances12 weeksas 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
SecondaryBlood glucose test for diabetes12 weeksas measured by fasting blood glucose levels in blood
SecondaryLiver function tests for clinical markers of liver injury12 weeksas measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
SecondaryBody Mass Index12 weeksas 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.
SecondaryNumber of cigarettes smoked daily, as measured by Time Line Follow Back12 weeks
SecondarySelf report of daily measures of expectancies, confidence and drinking12 weeksas measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
OtherThe moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days12 weeks
OtherCost-effectiveness of topiramate versus naltrexone, as measured by Disability-Adjusted Life Years (DALYs)12 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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