NCT01641445

Brief Summary

This study will help to determine whether the medication, topiramate, reduces alcohol use among adolescents with alcohol dependence. It will also help answer the question, "How does topiramate reduce drinking in teenagers?" Understanding how topiramate may reduce drinking in adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and help to identify additional medications that may hold promise for improving treatment outcomes for youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 17, 2020

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

July 11, 2012

Results QC Date

August 28, 2020

Last Update Submit

September 25, 2020

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • Alcohol Use

    Percent drinking days at the target medication dose

    Study Weeks 5-8

  • Heavy Drinking Days

    Percent heavy drinking days at the target medication dose. Heavy drinking is defined as 4 or more standard alcoholic drinks per day for females and 5 or more standard drinks per day for males.

    Study Weeks 5-8

Secondary Outcomes (2)

  • Alcohol Use

    6-month follow-up assessment

  • Alcohol Use

    12-month follow-up assessment

Study Arms (2)

Topiramate

ACTIVE COMPARATOR

Topiramate (200 mg) taken orally daily

Drug: Topiramate

Sugar pill

PLACEBO COMPARATOR

Placebo ("sugar pill") taken orally daily

Drug: Placebo

Interventions

TopiramateDRUG

Topiramate (200 mg daily)

Also known as: Topamax
Topiramate
PlaceboDRUG

Matching placebo capusules ("sugar pills"

Also known as: "Sugar Pill"
Sugar pill

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old (inclusive)
  • Non-treatment seeking for alcohol abuse or dependence
  • Interest in reducing alcohol use
  • Self-reported alcohol use at least 2 days/week during prior 28 days
  • Able to read simple English

You may not qualify if:

  • Alcohol or substance abuse treatment in the past 30 days
  • Clinically significant medical abnormalities
  • History of renal impairment, renal stones, or unstable hypertension
  • History of progressive neurodegenerative disorders or clinical significant neurological disorders
  • Body mass index lower than 18
  • Pregnant, nursing, or refusal to use reliable birth control, if female
  • Non-stabilized psychotropic medication and/or taking medication that is contraindicated for use with topiramate
  • Medications that may effect alcohol use or a carbonic anhydrase inhibitor
  • Suicidal or psychotic
  • Current coexisting substance use disorders other than alcohol, caffeine, cannabis, or nicotine use disorders
  • Clinically significant alcohol withdrawal symptoms
  • Impaired cognitive functioning
  • Living with an active study participant
  • Compelled to treatment by the juvenile justice system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

TopiramateSugars

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesCarbohydratesKetoses

Results Point of Contact

Title
Dr. Robert Miranda
Organization
Brown University
Robert_Miranda_Jr@brown.edu
401.863.6658

Study Officials

  • Robert Miranda, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research)

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 16, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2016

Study Completion

April 12, 2017

Last Updated

October 20, 2020

Results First Posted

September 17, 2020

Record last verified: 2020-09

Locations

US(1)