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Placebo
topiramate for Alcoholism
Phase 2 & 3
Waitlist Available
Led By Nassima Ait-Daoud Tiouririne, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females who have given written informed consent
Subjects must be above the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in the last 4 weeks of treatment
Awards & highlights
Study Summary
This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.
Eligible Conditions
- Alcoholism
- Nicotine Addiction
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the last 4 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the last 4 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
percent heavy drinking days, continuous abstinence rate for smoking
Secondary outcome measures
Craving for alcohol and nicotine
Quality of life Questionnaire
Side effects data
From 2008 Phase 4 trial • 250 Patients • NCT0106011152%
Paresthesia
17%
Weight decreased
9%
Headache
7%
Gastrointestinal disorder
7%
Paraesthesia
6%
Dizziness
6%
Anorexia
6%
Depression
5%
Dyspepsia
5%
Insomnia
4%
Somnolence
4%
Fatigue
2%
Feeling abnormal
1%
Nausea
1%
Psychomotor retardation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate Standard
Topiramate Slow
Topiramate Slow and Propranolol Booster
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: topiramateExperimental Treatment1 Intervention
topiramate with brief behavioral enhancement therapy
Group II: PlaceboPlacebo Group1 Intervention
Placebo with brief behavioral enhancement therapy
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,709 Total Patients Enrolled
7 Trials studying Alcoholism
26,322 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,690 Total Patients Enrolled
417 Trials studying Alcoholism
983,111 Patients Enrolled for Alcoholism
M.D. Anderson Cancer CenterOTHER
2,958 Previous Clinical Trials
1,798,155 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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