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NCT00884884 · ClinicalTrials.gov registry record · Phase 2
Aripiprazole and Topiramate on Free-Choice Alcohol Use
A Phase 2 study of Alcohol Dependence, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT00884884: Completed Phase 2 study of Alcohol Dependence, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT00884884 is a Phase 2 study of Alcohol Dependence that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 90 participants, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00884884, a Phase 2 study of Alcohol Dependence, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption. The primary aims are to: 1. determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol self-administration experiment (ASAE) 2. examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d) along with three doses of TPMT (0, 100mg/d and 200mg/d) 3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption 4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol dependent Participants (N=216) will be recruited from the community and randomly assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking.
Conditions Studied
Interventions
- DRUG Double Placebo
- DRUG Aripiprazole 15, placebo
- DRUG Aripiprazole 7.5, Placebo
- DRUG Topiramate 100, Placebo
- DRUG Topiramate 200, Placebo
Study Locations (1)
Rhode Island
- Brown University Center for Addiction Studies - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2007-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT00884884 record still lists
NCT00884884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 5 interventions - of which Double Placebo is the first listed.
NCT00884884 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00884884 about?
NCT00884884 is a clinical study titled "Aripiprazole and Topiramate on Free-Choice Alcohol Use". The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, a...
What is the current status of trial NCT00884884?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2007-09. Estimated completion is 2015-10.
What conditions does trial NCT00884884 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT00884884?
The interventions under investigation include: Double Placebo (DRUG), Aripiprazole 15, placebo (DRUG), Aripiprazole 7.5, Placebo (DRUG), Topiramate 100, Placebo (DRUG), Topiramate 200, Placebo (DRUG).
Who is sponsoring clinical trial NCT00884884?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00884884 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00884884's enrollment target sits among peer trials
90 22nd of 43 higher than 22 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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