Topiramate's Effects on Heavy Drinking (TOPMRI)

This is an interventional treatment trial for Alcohol Drinking Read More

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.