Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Paroxetine CR

About this trial

This is an interventional treatment trial for PTSD focused on measuring Substance Abuse, Trauma, Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Medical University of South Carolina

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)

Clinical Global Impressions Scale

Secondary Outcome Measures

Davidson Trauma Scale

Time-Line Follow-Back

Full Information

NCT ID

NCT00330239

First Posted

May 25, 2006

Last Updated

October 2, 2007

Sponsor

Medical University of South Carolina

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00330239

Brief Title

Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

Official Title

Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of South Carolina

Collaborators

GlaxoSmithKline

4. Oversight

5. Study Description

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.

Detailed Description

Participants who meet all inclusion and no exclusion criteria will be randomized with a 1:1 ratio to receive either Paxil CR or placebo for 12 weeks. Medication will be initiated at 12.5mg/day and will be increased weekly as tolerated to a maximum dose of 50mg/day. Participants will be seen weekly and will be assessed for side effects, substance use since last visit, urine drug screen, breathalyzer readings, vital signs and symptoms of PTSD (TOP-8)at each visit. The Davidson Trauma Scale will be completed every two weeks, and the CAPS-2 and MADRS will be completed monthly. Those who complete the first 12 weeks of double-blind study medication will be eligible to receive open label medication for an additional 12 weeks. Medication will be initiated at 12.5mg and increased every 3 days as tolerated to the terminal dose in the double-blind phase, then adjusted as needed. Participants will come in for assessments every two weeks of the open-label phase. Blood will be drawn for blood chemistries and hematology at screening and weeks 12 and 24. Urine pregnancy tests will be performed for women of childbearing potential at baseline and again at weeks 4, 12 and 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD

Keywords

Substance Abuse, Trauma, Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

25 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paroxetine CR

Primary Outcome Measure Information:

Title

Clinician Administered PTSD Scale (CAPS)

Title

Clinical Global Impressions Scale

Secondary Outcome Measure Information:

Title

Davidson Trauma Scale

Title

Time-Line Follow-Back

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan C Sonne, PharmD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kathleen T Brady, MD, PhD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

PTSD

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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