Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00330239 · ClinicalTrials.gov registry record · Phase 4

Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

A Phase 4 study of PTSD, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 4
Development phase
25
Enrollment target
1
Study location

NCT00330239 is a Phase 4 study of PTSD that has completed, run by Medical University of South Carolina. The registered enrollment target is 25 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00330239, a Phase 4 study of PTSD, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 4
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in treating this disorder. Currently there are two selective serotonin reuptake inhibitors (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this same class of medications has also been shown to have efficacy in some trials in decreasing alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as decreasing substance use, in individuals with concurrent substance dependence and PTSD. The type of paroxetine used in this trial will be Paxil CR®, which is a sustained release formulation of paroxetine, which has fewer side effects and greater tolerability. This is a particularly important issue in substance using populations because medication compliance is generally poor. Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their substance use outcomes (based on UDS and TLFB) than will those who receive placebo.

Conditions Studied

Interventions

  • DRUG Paroxetine CR

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2003-01
Est. Completion 2005-05
Phase Phase 4

What the Registry Record Tells You About NCT00330239

The ClinicalTrials.gov registry entry for NCT00330239 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (92% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which Paroxetine CR is the first listed.

NCT00330239 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT00330239 about?

NCT00330239 is a clinical study titled "Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence". Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in treating this disorder. Currently there are two selective serotonin reuptake inhibitors (Zoloft® and Paxil®), that have ...

What is the current status of trial NCT00330239?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2003-01. Estimated completion is 2005-05.

What conditions does trial NCT00330239 study?

This clinical trial studies the following conditions: PTSD.

What interventions are being tested in trial NCT00330239?

The interventions under investigation include: Paroxetine CR (DRUG).

Who is sponsoring clinical trial NCT00330239?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00330239 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for PTSD

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.