Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01113164 · ClinicalTrials.gov registry record · Phase 1
Matching Genotypes and Serotonergic Medications for Alcoholism
A Phase 1 study of Alcoholism, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT01113164 is a Phase 1 study of Alcoholism that has completed, run by Brown University. The registered enrollment target is 79 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01113164, a Phase 1 study of Alcoholism, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
Study Summary
Sertraline, a serotonin-specific reuptake inhibitor (SSRI) that increases basal serotonin levels, was shown to reduce alcohol consumption in lower risk/severity and later onset (LOA) but not higher risk/severity earlier onset alcoholic individuals (EOA). By contrast, ondansetron, a 5-HT3 receptor reduced alcohol consumption in EOAs but not LOAs. To explain this contrast in clinical efficacy, one approach suggests that differential serotonergic response is based on a functional polymorphism of the 5-HTTLPR promoter region of the serotonin re-uptake transporter (SERT). These alleles have typically been classified as biallelic genotypes: LL, SS and SL. The LL variant is postulated to be associated with EOA and the SS/SL variants associated with LOA. To test this hypothesis the investigators therefore propose to match and mismatch serotonergic treatments to genetic polymorphic variants \[in 132 non-treatment seeking alcohol dependent volunteers\] in a double-blind placebo controlled 2 x 2 design human laboratory study. The investigators propose to randomize non-treatment-seeking alcohol dependent persons based on their 5'-HTTLPR variant genotype (LL or SS/SL) into one of two counterbalanced arms: participants in the first arm (LL) will first receive one drug (either 200mg/day of sertraline or ondansetron 0.5mg/day) for three weeks followed by an alcohol self-administration experiment (ASAE), \[with a 1 week down-titration period if sertraline received first, during the first week of the "placebo period"\] then receive placebo for two more weeks (this will be a single-blind portion to use as a comparison group and to wash out the pharmacodynamic effects of the first drug) followed by a second ASAE. Participants will then receive the second drug for three weeks followed by a third ASAE \[all will receive medication for an additional 1 week period and those receiving sertraline last will be down-titrated\]. Participants in the second arm (SS/SL) will receive the same medic
Conditions Studied
Interventions
- DRUG Ondansetron and Sertraline
Study Locations (1)
Rhode Island
- Center for Alcohol and Addiction Studies - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01113164
The ClinicalTrials.gov registry entry for NCT01113164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (79% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 1 intervention - of which Ondansetron and Sertraline is the first listed.
NCT01113164 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT01113164 about?
NCT01113164 is a clinical study titled "Matching Genotypes and Serotonergic Medications for Alcoholism". Sertraline, a serotonin-specific reuptake inhibitor (SSRI) that increases basal serotonin levels, was shown to reduce alcohol consumption in lower risk/severity and later onset (LOA) but not higher risk/severity earlier onset alcoholic individuals (EOA). By contrast, ondansetron, a 5-HT3 receptor re...
What is the current status of trial NCT01113164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2008-09. Estimated completion is 2012-02.
What conditions does trial NCT01113164 study?
This clinical trial studies the following conditions: Alcoholism.
What interventions are being tested in trial NCT01113164?
The interventions under investigation include: Ondansetron and Sertraline (DRUG).
Who is sponsoring clinical trial NCT01113164?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01113164 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 Alcoholism
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.
-
N-acetylcysteine in Alcohol Dependence
COMPLETED · Phase 1
-
Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
COMPLETED · Phase 1
-
A Novel Compound for Alcoholism Treatment
COMPLETED · Phase 1
-
Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
COMPLETED · Phase 1
-
GSK1521498 Alcohol Interaction Study
COMPLETED · Phase 1
-
Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.