Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topiramate's Effects on Heavy Drinking (TOPMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02074904
Recruitment Status : Terminated (We terminated the study to run it as a sub-study of NCT02371889, which is a 13 week, placebo controlled, double-blind, trial of topiramate in heavy drinkers.)
First Posted : February 28, 2014
Results First Posted : December 11, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI) to examine the effects of topiramate on brain and behavioral responses in heavy drinkers to appetitive alcohol reminders (cues that motivate continued alcohol use and relapse). This project will yield novel findings on brain and behavioral responses to alcohol cues, the effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's ability to blunt alcohol cue reactivity and heavy drinking.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: Topiramate Drug: Placebo Phase 2

Detailed Description:
This project is a double-blind, randomized, placebo-controlled study of topiramate's effects on brain and behavior responses in heavy drinkers. Eligible volunteers who meet study criteria will be randomized to receive either topiramate or placebo with weekly visits and medication management sessions. Participants will complete two magnetic resonance imaging sessions. The first scan session will occur prior to starting study drug, and the second scan will occur following six weeks of study drug. This project will yield novel findings on brain and behavioral responses to alcohol cues, the effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's ability to blunt alcohol cue reactivity and heavy drinking.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brain Mechanisms of Topiramate's Effects on Heavy Drinking
Study Start Date : May 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: Topiramate
up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
Drug: Topiramate
Other Name: Topamax

Placebo Comparator: Placebo
placebo
Drug: Placebo



Primary Outcome Measures :
  1. fMRI Response in the Ventral Striatum/Medial Orbitofrontal Cortex During Alcohol Cue Exposure [ Time Frame: baseline to after 6 weeks of study drug ]
    At baseline (prior to randomization), brain and behavioral responses will be significantly greater during alcohol cue exposure compared to non-alcohol cue exposure. Following 6 weeks of study drug, individuals receiving topiramate will demonstrate greater reductions in brain activity and drinking behavior compared to individuals receiving placebo. Individuals receiving placebo will exhibit responses similar to baseline responses.


Secondary Outcome Measures :
  1. Drinking Days [ Time Frame: baseline and 9 weeks ]
    change in drinking days from baseline to 9 weeks

  2. Change in Gamma-glutamyl Transferase (GGT) or Carbohydrate-deficient Transferrin (CDT) Levels [ Time Frame: baseline and Visit 9 (9 weeks) ]
    Change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels after 9 weeks of treatment.

  3. Heavy Drinking Days [ Time Frame: baseline to 9 weeks ]
    change in number of heavy drinking days from baseline to 9 weeks

  4. Mean Alcohol Consumption [ Time Frame: baseline to 9 weeks ]
    change in mean alcohol consumption from baseline to 9 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074904


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Reagan R Wetherill, PhD University of Pennsylvania
Principal Investigator: Henry R Kranzler, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02074904     History of Changes
Other Study ID Numbers: TOP MRI
First Posted: February 28, 2014    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: September 21, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Drinking Behavior
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs