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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01228994
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults (18 years or older).
* Meet DSM-IV criteria for nicotine dependence,
* Smoke ≥10 cigarettes/day,
* Baseline FTND score ≥4, CO level ≥10,
* have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
* No previous use of medication for smoking cessation in 1 month prior to randomization.
* BMI between 15 and 40 inclusive.
Exclusion Criteria:
* Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
* Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
* Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
* Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
* Are pregnant, are trying to become pregnant or are currently breastfeeding
* Baclofen hypersensitivity .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01228994
Study Brief:
Protocol Section:
NCT01228994