Completed
Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
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
Alcoholism
+ Post-Traumatic Stress Disorder
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
This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial. All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.
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.Design Details
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.
How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alcoholism
Post-Traumatic Stress Disorder
Criteria
4 inclusion criteria required to participate
Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder
Laboratory tests for blood and urinalysis must be within normal limits
Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions
Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal
8 exclusion criteria prevent from participating
Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days
Currently suicidal
Medical reasons not to receive drug therapy
Allergy or hypersensitivity to selective serotonin inhibitor antidepressants
Show More Criteria
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
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
Suspended
Department of Psychiatry and Behavioral Science, Medical University of South CarolinaCharleston, United StatesSee the location
CompletedOne Study Center