Phase 4
Completed N=100
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Source: ClinicalTrials.gov NCT00381043 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: % Dropout — 21.5; 16.3 percentage of participants
Summary
This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Dropout |
21.5; 16.3 | — |
| PRIMARY Percent Days Abstinent |
40.7; 41.6 | — |
| SECONDARY Retention |
39; 41 | — |
| SECONDARY Percent With Complete Abstinence |
5.9; 19.1 | — |
| SECONDARY % Heavy Drinking Days During Trial |
15.8; 18.4 | — |
| SECONDARY Clinical Global Impression Scale |
2.3; 2.4 | — |
| SECONDARY % Compliant With Medication |
93.3; 91.6 | — |
Eligibility Criteria
INCLUSION CRITERIA
- 1. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.
- 2. History of at least 2 heavy drinking days (men > 5 drinks/day; women > 4 drinks/day) per week, on average, during the month prior to screening.
- 3. Ability to understand and sign written informed consent.
- 4. Willingness to refrain from drinking for at least three days prior to randomization.
- 5. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.
EXCLUSION CRITERIA
- 1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern.
- 2. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. [Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.]
- 3. Suicidal ideation or behavior, history of suicide attempt.
- 4. Renal Impairment; estimated creatinine clearance <50 ml/min.
- 5. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
- 6. Pregnant or breastfeeding women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
- 7. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. Individuals may be considered for the trial upon completion of medical detoxification.
Data sourced from ClinicalTrials.gov (NCT00381043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.