Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01941693
Eligibility Criteria:
Inclusion Criteria for Step 1:
* alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
* age 18-65,
* adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
* willingness to give written consent,
* abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
* resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).
Exclusion Criteria for Step 1:
* sensitivity to study medications or therapy with these drugs within 6 months,
* active major psychiatric disorder associated with significant suicide risk,
* pregnancy or lactation,
* advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
* other serious medical illness that would interfere with adherence to the study protocol.
Entry criteria to step 2:
* Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
* case formulation and diagnosis for anxiety or depression (see below).
Exclusion criteria 2:
* Non-compliance on acamprosate and/or naltrexone,
* alcohol consumption at baseline levels,
* resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01941693
Study Brief:
Protocol Section:
NCT01941693