Completed

Sertraline Treatment for Comorbid PTSD and Alcoholism

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

sertraline (Zoloft)

Drug
Who is being recruted

Trauma and Stressor Related Disorders+5

+ Mental Disorders

+ Substance-Related Disorders

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

The study focuses on individuals who have both post-traumatic stress disorder (PTSD) and alcoholism. Its main goal is to explore if a medication called sertraline (Zoloft) can help reduce alcohol consumption and PTSD symptoms related to crime in these individuals. This research is important as it aims to find a treatment that can address both conditions simultaneously, potentially improving the quality of life for those affected. The study lasts for 12 weeks and is designed as a placebo-controlled, double-blind outpatient trial. This means some participants will receive sertraline, while others will receive a placebo, a pill that looks like sertraline but contains no active medication. Neither the participants nor the researchers will know who is receiving which. All participants will also receive cognitive behavioral therapy, a type of talk therapy. Evaluations will take place at the start of the study, at the end of treatment, and at 6, 9, and 12 months after the study begins.

NCT00000446
Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersSubstance-Related DisordersAlcohol-Related DisordersStress Disorders, TraumaticChemically-Induced DisordersAlcoholismStress Disorders, Post-Traumatic

Criteria

4 inclusion criteria required to participate
Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal
Laboratory tests for blood and urinalysis must be within normal limits
Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder
Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions
8 exclusion criteria prevent from participating
Allergy or hypersensitivity to selective serotonin inhibitor antidepressants
Currently suicidal
Females who are pregnant or lactating
Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Psychiatry and Behavioral Science, Medical University of South Carolina

Charleston, United StatesOpen Department of Psychiatry and Behavioral Science, Medical University of South Carolina in Google Maps
CompletedOne Study Center