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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT01343628
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 21 - 45, as verified upon the presentation of a valid, government issued form of ID
* Current DSM-IV diagnosis of alcohol dependence using the Mini International Neuropsychiatric Interview (MINI). Which is a shortened form of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders or SCID. The MINI will also be used to exclude patients with other diagnoses.
* Participants do not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) Axis I disorder (including ADHD treated with medication), other than cocaine dependence or those listed above, that warrants treatment or would preclude safe participation in the protocol
* Not currently take medications that are contraindicated for concurrent use with alcohol;
* No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data;
* No recurring past history of severe hypertension, glaucoma, hyperthyroidism, circulatory disease, hepatitis, chronic liver disease, ulcer disease, seizure disorder, brain disease, cardiac disease, obstructed bowel, or other current treatment of medical conditions that could determine ineligibility;
* Female subjects must not be breastfeeding and must not be pregnant, as indicated by a pregnancy test that will be conducted immediately prior dispensing of medication.
* Subjects have to have normal EKGs results
* Pulse less than 100 beats per minute
* Participants have to weigh between 125-290; weighing between 125-195 lbs (57 - 88.5 kg)
Exclusion Criteria:
* Significant medical illness (including severe hypertension) as determined by history and/or complete physical examination. (Note: Presence of mild to moderate chronic diseases not otherwise specifically excluded, that are well controlled by medications/interventions will not be considered clinically significant. However the presence of medical disease that is not well controlled will be considered exclusionary.)
* tachycardia
* seizure disorder
* prior history of myocardial infarction
* Clinically significant cardiovascular disease that precludes safe participation
* hepatic or renal impairment; (ie: liver or kidney enzymes \> 3x normal limits)
* pregnant
* currently using MAO inhibitors within 14 days
* narrow angle glaucoma
* currently taking antidepressants or have taken within the last month
* currently taking pressor agents such as:
* Alprenolol
* Carteolol
* Levobunolol
* Mepindolol
* Metipranolol
* Nadolol
* Oxprenolol
* Penbutolol
* Pindolol
* Propranolol
* Sotalol
* Timolol
* Acebutolol
* Atenolol
* Betaxolol
* Bisoprolol\[16\]
* Esmolol
* Metoprolol
* Nebivolol
* Carvedilol
* Celiprolol
* Labetalol
* Butaxamine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT01343628
Study Brief:
Protocol Section:
NCT01343628