Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence - Full Text View

Sponsors and Collaborators:	Medical University of South Carolina GlaxoSmithKline
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00330239

Purpose

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.

Condition	Intervention	Phase
PTSD	Drug: Paroxetine CR	Phase IV

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Clinician Administered PTSD Scale (CAPS)
Clinical Global Impressions Scale

Secondary Outcome Measures:

Davidson Trauma Scale
Time-Line Follow-Back

Estimated Enrollment:	25
Study Start Date:	January 2003
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330239

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29464

Sponsors and Collaborators

Medical University of South Carolina

GlaxoSmithKline

Investigators

Principal Investigator:	Susan C Sonne, PharmD	Medical University of South Carolina
Principal Investigator:	Kathleen T Brady, MD, PhD	Medical University of South Carolina

More Information

Study ID Numbers:	CPMS-857
Study First Received:	May 25, 2006
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00330239
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

Substance Abuse
Trauma
Dependence

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Substance-Related Disorders
Wounds and Injuries
Disorders of Environmental Origin

Stress Disorders, Post-Traumatic
Stress
Paroxetine
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009