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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02074904
Eligibility Criteria:
Inclusion Criteria:
* Physically healthy, as determined by a comprehensive physical examination and approval of the study physician, males or females who drink alcohol, ages 18-60.
* Average weekly ethanol consumption of \>24 standard drinks for men, or \>18 standard drinks for women.
* Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 2 years postmenopausal) or of child bearing potential but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
* Provide voluntary informed consent.
* Must be able to read. \[Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.\]
* Intelligence quotient of ≥ 80.
Exclusion Criteria:
* Current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation.
* History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
* Current major DSM-IV Axis I diagnoses other than alcohol use disorder (except nicotine use disorder).
* Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
* History of a serious psychiatric illness including psychosis, bipolar disorder, or suicidal or homicidal intent.
* Current treatment with carbonic anhydrase inhibitors.
* Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.
* Current regular treatment with psychotropic medications (e.g., benzodiazepines, antidepressants), which affect neurotransmitter systems or a medication being used to treat alcohol use disorders (e.g., naltrexone, acamprosate).
* Vision problems that cannot be corrected with glasses.
* Body Mass Index (BMI) greater than or equal to 34, body girth greater than 52 inches and a head girth greater than 25 inches.
* History of stroke and/or stroke related spasticity.
* History of glaucoma or kidney stones.
* HIV positive.
* History of seizures.
* History of topiramate treatment for alcohol use disorder and report no treatment response.
* Current DSM-5 diagnosis of alcohol use disorder that is clinically too severe to permit them to participate in a research trial in which the goal is to stop or reduce drinking.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02074904
Study Brief:
Protocol Section:
NCT02074904