AlcoholismPhase 2NCT00000446
Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
A Phase 2 study testing sertraline (Zoloft) in people with Alcoholism and Post-Traumatic Stress Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Post-Traumatic Stress Disorder
- What is being tested?
- sertraline (Zoloft)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
- Liver function test greater than 2 times the normal level
- Require ongoing therapy with another psychoactive drug during the study period.
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry and Behavioral Science, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
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.
- Conditions
- Alcoholism, Post-Traumatic Stress Disorder
- Being tested
- sertraline (Zoloft)
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline (Zoloft)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000446
- Sponsor's protocol ID
- NIAAABRA10761
- Status last verified
- Apr 2004
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
- ClinicalTrials.gov ID
- NCT00000446
- Acronym / sponsor ID
- NIAAABRA10761
- Conditions
- Alcoholism, Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study completion
- Dec 2000
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertraline (Zoloft) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sertraline (Zoloft) in people with Alcoholism and Post-Traumatic Stress Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.