Trial · NCT03479086
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of heavy drinking days, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with Phosphatidylethanol (PEth) levels |
| Primary | Time to relapse, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Time to lapse, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Number of days abstinent, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Number of standard drinks per drinking day, as measured by the Time Line Follow Back | 12 weeks | Corroborated with PEth levels |
| Secondary | Self report of adverse events | 12 weeks | as reported by patient during weekly medical management sessions facilitated by the treating doctor. |
| Secondary | Penn Alcohol Craving Scale for alcohol craving | 12 weeks | 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. |
| Secondary | DASS21 score for presence and/or severity of anxiety | 12 weeks | as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21). |
| Secondary | DASS21 score for presence and/or severity of depression | 12 weeks | as measured by cumulative score for depression related questions |
| Secondary | Insomnia Severity Index for sleep disturbances | 12 weeks | 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 |
| Secondary | Blood glucose test for diabetes | 12 weeks | as measured by fasting blood glucose levels in blood |
| Secondary | Liver function tests for clinical markers of liver injury | 12 weeks | as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood |
| Secondary | Body Mass Index | 12 weeks | 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. |
| Secondary | Number of cigarettes smoked daily, as measured by Time Line Follow Back | 12 weeks | |
| Secondary | Self report of daily measures of expectancies, confidence and drinking | 12 weeks | as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed. |
| Other | The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days | 12 weeks | |
| Other | Cost-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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03479086/registered