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Trial record 12 of 123 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism

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ClinicalTrials.gov Identifier: NCT02901041
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Mclean Hospital
University of Houston
Information provided by (Responsible Party):
David H. Barlow, Boston University Charles River Campus

Brief Summary:

Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000 deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however, approved medications for the treatment of AUD has shown limited effectiveness.

Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of action seems to be quite distinct from currently approved anti-alcoholism medications, which holds promise for treatment of individuals who are not responsive to conventional medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's efficacy in treating patients with a diagnosis of AUD.

To fill in these gaps, the investigators will conduct a double-blind randomized controlled study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol consumption in patients with AUD. Participants will be randomized to one of two conditions: 1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2) treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as well as an alcohol related cues task.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Zonisamide Behavioral: Take Control Drug: Placebo (for Zonisamide) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arm Intervention/treatment
Experimental: Zonisamide & Computerized Psychotherapy
Zonisamide capsules (with a target maintenance dose of 400 mg daily) and a seven module computerized psychotherapy for alcohol use disorders called Take Control (9 sessions) will be administered over the course of 12 weeks, followed by a two week medication taper.
Drug: Zonisamide
ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. A dose of 400 mg daily will be used as the target maintenance dose in this study but dosing will be modified if needed to adjust for subject tolerance of drug dosing.
Other Name: Zonegran

Behavioral: Take Control
Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.

Active Comparator: Placebo & Computerized Psychotherapy
Placebo capsules (for zonisamide) and a seven module computerized psychotherapy for alcohol use disorders called Take Control will be administered over the course of 14 weeks.
Behavioral: Take Control
Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.

Drug: Placebo (for Zonisamide)
Sugar pills manufactured to mimic Zonisamide capsules.




Primary Outcome Measures :
  1. Alcohol Consumption [ Time Frame: Change from baseline following 12-week treatment ]
    Drinking measures derived from Time Line Follow Back data will include the percent days drinking, the number of drinks consumed per day, and the percent days heavy drinking. Heavy drinking will be defined as 4 or more drinks per day for women and 5 or more drinks per day for men.


Secondary Outcome Measures :
  1. Risk Task - Risk Taking Behavior [ Time Frame: Change from baseline at conclusion of 12-week treatment ]
    The Risk Task (Rogers et al., 1999) measures decision-making under risk.

  2. Cued Go/No-go Task - Impulsivity [ Time Frame: Change from baseline at conclusion of 12-week treatment ]
    The cued go no-go task (Fillmore, 2003) measures impulse control by the ability to inhibit instigated, "prepotent" responses.

  3. Balloon Analogue Risk Task - Risk Taking Behavior [ Time Frame: Change from baseline at conclusion of 12-week treatment ]
    The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss.

  4. Connors Continuous Performance Task - Impulsivity [ Time Frame: Change from baseline at conclusion of 12-week treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-5 diagnosis of an Alcohol Use Disorder (AUD)
  • Adults ages 21 to 65 years old
  • Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption
  • Reported drinking an average of at least 35 standard drinks per week for males, or 28 for females occurring over a 28 consecutive day period during the 90 day-long time window that preceded the screening session
  • Must be willing to discontinue psychotherapy for substance use disorder (except A.A.)

Exclusion Criteria:

  • Bipolar disorder, schizophrenia, current bulimia/anorexia, dementia, or other substance use disorder, with the exception of nicotine, marijuana, and caffeine
  • Clear and current suicidal risk
  • Significant medical problem (e.g. uncontrolled diabetes)
  • Medical contraindication to the use of ZON (e.g. history of significant renal disease, kidney stones, liver problems, metabolic acidosis, etc), as indicated by the FDA Zonisamide medication guide
  • History of anticonvulsant-induced rash
  • Currently taking:

    1. acamprosate, naltrexone, topiramate, disulfiram, or benzodiazepines
    2. a medication that is a moderate or major inhibitor or inducer of cytochrome P450 3A4 enzymes
    3. an amphetamine or other psychomotor stimulant
    4. opioids or have been treated chronically with opioids
    5. antipsychotic agents, anticonvulsants, or sedative hypnotics
    6. drugs with "sulfa" moiety (e.g. sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics), except ethacrynic acid
    7. anxiolytics or antidepressants
  • Previously received ZON for the treatment of an AUD
  • Known allergy to sulfonamides
  • Implantation of anything containing magnetically sensitive material including metal plates, aneurysm clips, and cardiac pacemakers, stents
  • Non-English speakers
  • Pregnant women or women who are lactating (breastfeeding)

Exclusion from Screening:

  • Reduction in the mean number of drinks consumed per week for the pre-screening period by 50% or more during the screening period or report of average drinks per day fall within safe levels of alcohol consumption (i.e. 2 drinks/day for males and 1 drink/day for females by the HHS standard) two weeks prior to screening
  • Women of child bearing potential (not postmenopausal for at least one year) will not be admitted into this study unless they are found to have a negative HCG test during screening. If they pass the HCG screening, they will be asked to maintain the use of an effective means of contraception during the course of the study
  • Blood test shows lower than average red or white blood cell count or higher than average level of acid in blood

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): NCT02901041


Contacts
Contact: Todd Farchione, PhD 617-353-9610 tfarchio@bu.edu

Locations
United States, Massachusetts
Center for Anxiety and Related Disorders - Boston University Recruiting
Boston, Massachusetts, United States, 02115
Contact: David H Barlow, PhD    627-353-9610      
Sponsors and Collaborators
Boston University Charles River Campus
Mclean Hospital
University of Houston
Investigators
Principal Investigator: David H Barlow, PhD Boston University

Responsible Party: David H. Barlow, Principal Investigator, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT02901041     History of Changes
Other Study ID Numbers: 2R01AA015923-06 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Zonisamide
Anticonvulsants
Salicylic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents