A Phase 1/2 interventional study of Topiramate and Placebo in Alcohol Drinking, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Brown University · Phase 1/2, Interventional, and Treatment
Among 22 studies in Alcohol Drinking by Brown University — 3 open to participants now, 3 under way, none of them phase 3. Alcohol Drinking · Brown University.
Among the 22 studies in Alcohol Drinking by Brown University, this one is the 13th largest by enrollment, is one of 2 that started in 2012, is the only one in phase 1/2, and was the 5th registered.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 82 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →3 of the 22 studies in Alcohol Drinking by Brown University are open now, in 1 country. Each count lists the studies.
Of the 97 Alcohol Drinking studies recruiting now, 37 (38%) set no upper age limit and 52 (54%) stop at 75 or younger; 10 take children under 18; 47 take healthy volunteers.
This study: 14 Years to 24 Years · all sexes · healthy volunteers too.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2012.
Median enrollment 117 across the 22 interventional studies. Of the 18 that completed or were terminated, 11 (61%) have results posted.
Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
2 of the studies in Alcohol Drinking by Brown University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07663448Brown UniversityTargeting Alcohol-Opioid Co-Use Among Young Adults Using a Novel MHealth Intervention | 2027-04-30 |
| NCT05389930Brown UniversityCannabis' Impact on Alcohol Consumption | 2027-08-31 |
Among the 22 studies in Alcohol Drinking by Brown University, from their registry updates:
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.
Adolescent alcohol use is associated with myriad adverse legal, health, and educational consequences and contributes to the leading causes of mortality among youth. Yet despite the magnitude of this public health problem, treatment initiatives for youth remain inadequate. Given these data, the National Institute on Alcohol Abuse and Alcoholism identified the critical need for medications development research for youth with the goal of identifying promising agents for which large-scale clinical trials are justified. The long-term goal of this research program is to improve pharmacotherapy for alcoholism. The major objective of this project is to address the urgent need for empirical data on medications that may benefit youth. For the past 10 years our research program has successfully paired human laboratory paradigms with ecological momentary assessment (EMA), whereby research participants use handheld electronic diaries to monitor their drinking, craving, and sensitivity to alcohol in real time in their natural environment. Using this approach, we identified mechanisms by which medications act and patient characteristics that moderate these effects. The proposed study will test if and how topiramate (TPM), an anticonvulsant shown to be efficacious for treating adults, reduces drinking in youth. To this end, we will randomize adolescent problem drinkers to TPM or placebo for 8 weeks, in combination with biweekly motivational enhancement therapy sessions, using a two-group, double-blind design. While at the target dose (200 mg/day) youth will complete EMA in their natural environment. In addition, youth will complete alcohol cue reactivity assessments in the laboratory to test the effects of TPM on cue-elicited craving and physiological reactivity in a controlled environment. Youth will complete 6- and 12-month follow-up assessments to determine whether any benefits are sustained. This study will provide much needed data on the tolerability and efficacy of TPM with adolescents, while adding important new information about the biobehavioral mechanisms of TPM action in youth.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topiramate (200 mg) taken orally daily
Drug: Topiramate
Placebo ("sugar pill") taken orally daily
Drug: Placebo
Topiramate (200 mg daily)
Also known as: Topamax
Matching placebo capusules ("sugar pills"
Also known as: "Sugar Pill"
Alcohol Use
Percent drinking days at the target medication dose
Time frame: 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.
Time frame: Study Weeks 5-8
Alcohol Use
Percent drinking days at the 6-month follow-up assessment
Time frame: 6-month follow-up assessment
Alcohol Use
Percent drinking days at the 12-month follow-up assessment
Time frame: 12-month follow-up assessment
| Milestone | Topiramate | Sugar Pill |
|---|---|---|
| Started | 41 | 41 |
| Completed | 31 | 36 |
| Not completed | 10 | 5 |
Percent drinking days at the target medication dose
| Percent of days | Topiramate | Sugar Pill |
|---|---|---|
| Alcohol Use | 29.59 ± 19.55 | 27.08 ± 21.47 |
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.
| percentage of days | Topiramate | Sugar Pill |
|---|---|---|
| Heavy Drinking Days | 9.34 ± 10.99 | 6.78 ± 11.44 |
Percent drinking days at the 6-month follow-up assessment
| Percent of days | Topiramate | Sugar Pill |
|---|---|---|
| Alcohol Use | 23.56 ± 17.11 | 21.75 ± 21.50 |
Percent drinking days at the 12-month follow-up assessment
| Percent of days | Topiramate | Sugar Pill |
|---|---|---|
| Alcohol Use | 25.55 ± 22.03 | 21.93 ± 21.73 |
Collected over Adverse events were collected during the 8-week active medication (or placebo pill) period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topiramate | 0/41 (0%) | 0/41 (0%) | 37/41 (90.2%) |
| Sugar Pill | 0/41 (0%) | 0/41 (0%) | 35/41 (85.4%) |
| Event | Topiramate | Sugar Pill |
|---|---|---|
| ParesthesiasGeneral disorders | 22/41 | 2/41 |
| Runny Nose, Sinus Problems, SneezingGeneral disorders | 14/41 | 17/41 |
| Drowsiness or SleepinessGeneral disorders | 16/41 | 10/41 |
| AnxietyPsychiatric disorders | 14/41 | 4/41 |
| Word Finding DifficultiesPsychiatric disorders | 13/41 | 3/41 |
| Difficulty with Concentration or AttentionPsychiatric disorders | 13/41 | 3/41 |
| Weight LossGeneral disorders | 13/41 | 11/41 |
| Decrease in AppetiteGeneral disorders | 13/41 | 6/41 |
| HeadacheGeneral disorders | 12/41 | 13/41 |
| Slow Thinking or ReactionsGeneral disorders | 12/41 | 3/41 |
| Age, Continuous(Years) | Topiramate | Sugar Pill | Total |
|---|---|---|---|
| Mean | 20.88 ± 2.08 | 20.49 ± 2.05 | 20.68 ± 2.06 |
| Sex: Female, Male(Participants) | Topiramate | Sugar Pill | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 21 | 21 | 42 |
| Region of Enrollment(Participants) | Topiramate | Sugar Pill | Total |
|---|---|---|---|
| United States | 41 | 41 | 82 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topiramate