Trial · NCT01641445

Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

NCT01641445, Phase 1, Phase 2, Completed, Brown University; results first posted 2020-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms. Trials, record NCT01641445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01641445

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
NCT number: NCT01641445
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 82 participants, actual
Lead sponsor: Brown University
Conditions: Alcohol Drinking
Interventions: Topiramate, Placebo
First posted: 2012-07-16
Last updated: 2020-10-20
Results first posted: 2020-09-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Alcohol Use	Study Weeks 5-8	Percent drinking days at the target medication dose
Primary	Heavy Drinking Days	Study Weeks 5-8	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.
Secondary	Alcohol Use	6-month follow-up assessment	Percent drinking days at the 6-month follow-up assessment
Secondary	Alcohol Use	12-month follow-up assessment	Percent drinking days at the 12-month follow-up assessment

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Alcohol Use	Study Weeks 5-8	Percent of days	MEAN
PRIMARY	Heavy Drinking Days	Study Weeks 5-8	percentage of days	MEAN
SECONDARY	Alcohol Use	6-month follow-up assessment	Percent of days	MEAN
SECONDARY	Alcohol Use	12-month follow-up assessment	Percent of days	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Alcohol Use	Topiramate	29.59	Standard Deviation 19.55	Percent of days
Alcohol Use	Sugar Pill	27.08	Standard Deviation 21.47	Percent of days
Heavy Drinking Days	Topiramate	9.34	Standard Deviation 10.99	percentage of days
Heavy Drinking Days	Sugar Pill	6.78	Standard Deviation 11.44	percentage of days
Alcohol Use	Topiramate	23.56	Standard Deviation 17.11	Percent of days
Alcohol Use	Sugar Pill	21.75	Standard Deviation 21.50	Percent of days
Alcohol Use	Topiramate	25.55	Standard Deviation 22.03	Percent of days
Alcohol Use	Sugar Pill	21.93	Standard Deviation 21.73	Percent of days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	41
Overall Study	STARTED	Sugar Pill	41
Overall Study	COMPLETED	Topiramate	31
Overall Study	COMPLETED	Sugar Pill	36
Overall Study	NOT COMPLETED	Topiramate	10
Overall Study	NOT COMPLETED	Sugar Pill	5

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Slow Thinking or Reactions	General disorders	Topiramate	12	41
other	Slow Thinking or Reactions	General disorders	Sugar Pill	3	41
other	Nervousness	Psychiatric disorders	Topiramate	4	41
other	Nervousness	Psychiatric disorders	Sugar Pill	2	41
other	Anxiety	Psychiatric disorders	Topiramate	14	41
other	Anxiety	Psychiatric disorders	Sugar Pill	4	41
other	Difficulty with Memory	Psychiatric disorders	Topiramate	12	41
other	Difficulty with Memory	Psychiatric disorders	Sugar Pill	4	41
other	Word Finding Difficulties	Psychiatric disorders	Topiramate	13	41
other	Word Finding Difficulties	Psychiatric disorders	Sugar Pill	3	41

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate	0	41
Total, all-cause mortality	Sugar Pill	0	41
Total, other adverse events	Topiramate	37	41
Total, other adverse events	Sugar Pill	35	41
Total, serious adverse events	Topiramate	0	41
Total, serious adverse events	Sugar Pill	0	41

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AA007850	Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms	MIRANDA, ROBERT	BROWN UNIVERSITY	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	1988 to 2015

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Topiramate vs Sugar Pill: deaths from any cause	Trial comparisons
Topiramate vs Sugar Pill: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01641445

GET https://conductscience.org/api/trials/v1/NCT01641445/events?page=2

API reference For AI assistants