Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

NCT00330239 | Completed Phase 4

• 1 other identifier: CPMS-857
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

PTSD

Keywords

Substance Abuse; Trauma; Dependence

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS)

• Clinical Global Impressions Scale

Secondary Outcomes (2)

• Davidson Trauma Scale

• Time-Line Follow-Back

Interventions

Paroxetine CR DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 65
• Outpatients who meet DSM-IV criteria for PTSD, chronic subtype, based on CAPS-1
• Must have a minimum score of 50 on the CAPS-2 at Baseline
• Must meet DSM-IV criteria for a substance dependence disorder in the last 3 months (excluding caffeine and nicotine)
• Must be able to read English
• Must give written informed consent

You may not qualify if:

• Individuals with a primary psychiatric disorder other than PTSD
• Individuals with an uncontrolled neurologic condition that could confound the results of the study (e.g. seizure disorder)
• Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize subject safety
• Concomitant use of other psychotropic medications (intermittent use of diphenhydramine and zolpidem will be allowed during the study) see concommitant meds on page 5 of the protocol
• Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
• Individuals who have failed an adequate trial of paroxetine in the past
• Current suicidal or homicidal risk
• Currently receiving trauma-specific psychotherapy
• Individuals taking any herbal psychoactive treatments (e.g. St. John's Wart)
• Individuals engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorder
• Individuals, who in the investigator's opinion would be unable to comply with study procedures or assessments

Sponsors & Collaborators

• Medical University of South Carolina: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Susan C Sonne, PharmD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Kathleen T Brady, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 26, 2006
• Study Start: January 1, 2003
• Study Completion: May 1, 2005
• Last Updated: October 3, 2007

Record last verified: 2007-10

Locations

US (1)