Topiramate Treatment of Alcohol Use Disorders in African Americans

NCT03018704 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: NURA-010-16S
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs), AAs have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the higher rates of morbidity and mortality, pharmacological treatments are understudied in this population and there is some evidence that medications are less preferred and less effective in AAs.

Conditions

Alcohol Use Disorder

Keywords

alcoholism; treatment

Outcome Measures

Primary Outcomes (1)

• Percent Days of Heavy Drinking

  Drinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (\>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

a placebo control arm

Drug: placebo

Topiramate

EXPERIMENTAL

Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients. The medication was dosed orally twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.

Drug: Topiramate

Interventions

Topiramate DRUG

anticonvulsant medication. The medication was dosed twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.

Also known as: Topamax

Topiramate

placebo DRUG

inactive medication. the doses of placebo were titrated the same as the active intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identification as African American;
• age 18 to 70 years, inclusive;
• average weekly ethanol consumption of \>24 standard drinks for men or \>18 standard drinks for women, with a weekly average of \> 2 heavy drinking days (men: \> 5 standard drinks; women: \> 4 standard drinks) during the month before screening;
• a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
• expressed goal to reduce or stop drinking;
• able to read English at the 6th grade or higher level and without gross cognitive impairment;
• women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment
• willing and able to provide signed, informed consent to participate in the study.

You may not qualify if:

• a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of \>110% or a transaminase elevation \>300% of normal;
• history of nephrolithiasis;
• history of glaucoma;
• current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, antisocial personality disorder, or imminent suicide or violence risk);
• current moderate-to-severe alcohol withdrawal requiring pharmacological treatment (see Section D.4.a. regarding alcohol detoxification);
• a history of hypersensitivity to TOP;
• current regular treatment with more than one antidepressant or any treatment with a tricyclic antidepressant;
• current treatment with a psychotropic medication (with the exception of antidepressants where monotherapy is allowable), including medications that, when combined with alcohol or TOP, present a risk of overdose or significant adverse effect (e.g., chronic opioid use) (of note we will allow subjects to discontinue medications that have no demonstrated therapeutic effect in order to enroll - amount of time off of the medication will be a clinical decision left to the discretion of the study physician investigators);
• current treatment with TOP or a medication approved for AUD;
• considered to be unsuitable candidates for receipt of an investigational drug;
• treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis,
• Body Mass Index (BMI) of less than 18.5.
• untreated gout as topiramate has been shown in one study to increase uric acid.
• current treatment with dolutegravir.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

The study was stopped by the funding agency due to difficulty recruiting during COVID pandemic

Results Point of Contact

• Title: David Oslin
• Organization: Department of Veteran Affairs

dave.oslin@va.gov

215-823-5894

Study Officials

• David W. Oslin, MD

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)