Status:
COMPLETED
Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
PTSD
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 disord...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00330239
Start Date
January 1 2003
End Date
May 1 2005
Last Update
October 3 2007
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29464