Trial · NCT03663374
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 | Change from baseline in the mean daily alcohol consumption | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | Calculated as total number of drinks in month divided by number of days in month. |
| Secondary | Change in the number of days of abstinence per month as compared to the baseline | Baseline and Week 24 of treatment | |
| Secondary | Change in the percentage of days of heavy drinking per month as compared to the baseline | Baseline and Week 24 of treatment | Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women. |
| Secondary | Time to the first day of drinking | From baseline till the first day of alcohol consumption | Full abstinence period duration. |
| Secondary | Time to the first day of heavy drinking | From baseline till the first day of heavy drinking | Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women. |
| Secondary | Change from baseline in alcohol consumption per drinking day | Baseline and Week Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 of treatment | Calculated as total number of drinks in month divided by number of drinking days in month. |
| Secondary | Change in alcohol craving from the baseline (based on Obsessive-Compulsive Drinking Scale (OCDS) score) | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | The OCDS is a validated scale consisted of 14 items for patient self-assessment of alcohol craving. Scoring by simple addition. Higher scores indicate greater level of craving (Anton R.F., Moak D.H., Latham P.K., 1996). |
| Secondary | Change in alcohol craving (based on completed VIsual Analogue Scale) | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | VIsual Analogue Scale (VAS) ranged from 0 to 100, where 0 corresponds to "no craving at all" and 100 corresponds to "maximal craving" |
| Secondary | Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) as compared to the baseline | Baseline and Week 8, 24 of treatment | The Short Form Health Survey (SF-36) is a validated 36 item self-report Quality of Life Questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception. Version 2 was used. (Ware J.E., 2000) |
| Secondary | Proportion of patient with clinical improvement as assessed by Clinical Global Impression-improvement (CGI-I) scale | Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | CGI-I scale is a 7 point scale that requires the investigator to assess how much the patient's illness has improved or worsened relative to a baseline. Rated as: 1 - very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse. (Guy W, 1970; 1976) |
| Secondary | Efficacy index of CGI | Week 12 and 24 of treatment | Efficacy index is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication (with possible considerations: 1 - unchanged or worse; 2 - minimal - slight improvement which doesn't alter status of care of patient; 3 - moderate marked - decided improvement, partial remission of symptoms; 4 - marked - vast improvement, complete or nearly complete remission of all symptoms) and associated side effects (with possible considerations: 1 - none; 2 - do not significantly interfere with patient's functioning; 3 - significantly interfere with patient's functioning; 4 - outweigh therapeutic effect). Derived by dividing therapeutic effect score by side effects score. The lower efficacy index corresponds to the better result (Guy W, 1970; 1976) |
| Secondary | Change from baseline in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score | 3 previous months, baseline and Week 4, 8, 12, 16, 20 and 24 of treatment | DrInC-2R is a validated self-report questionnaire consisted of 50 questions to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal as well as frequency of these consequences (answers given on frequency scale grade from 0-3: 0 - never, 1 - once or a few times, 2 - once or twice a week 3 - daily or almost daily). Higher scores indicate greater levels of alcohol-related problems. (Miller W.R., 1995) |
| Secondary | Change in impulsivity (Barratt impulsivity scale by the subscales and by the total score) from the baseline | Baseline and Week 8, 16 and 24 of treatment | Barratt impulsivity scale (BIS-11) is a validated self-report questionnaire composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4. Total score is assessed. The higher total score corresponds to the more impulsive behavior (Patton et al., 1995) |
| Secondary | Proportion of patients completed the trial | Week 24 of treatment | |
| Secondary | Time to untimely withdrawal from the study | From baseline to Week 24 of treatment | |
| Secondary | Number of the early dropouts from the study | Week 24 of treatment | Per reasons |
| Other | Number of hospitalizations due to alcohol intoxication | 6 month prior to the baseline and week 28 of treatment |
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.
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GET https://conductscience.org/api/trials/v1/NCT03663374/registered