AlcoholismPhase 4NCT00352469
Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
A Phase 4 study testing Seroquel XR in people with Alcoholism and Anxiety Disorders, run by Creighton University at 1 site in United States.
Trial summary
Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3 approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety disorders is unknown. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder
- What is being tested?
- Seroquel XR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Nov 2008
- Phase
- Phase 4
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of alcohol dependence and an anxiety disorder (generalized anxiety disorder, post traumatic disorder, panic disorder, obsessive compulsive disorder, etc.) based on Mini-International Neuropsychiatric Interview (MINI) for DSM IV.
- Subject reports a minimum of 48 standard alcoholic drinks (or an average of 12 drinks/wk) in a consecutive 30-day period (i.e., a minimum of 40% days drinking), and has 2 or more days of heavy drinking (defined as ≥5 drinks/day in males and ≥4 drinks/day in females) in this same period as measured by the Time Line Follow Back.
- Male and female patients between 19-65 years of age.
- Ability to provide informed consent.
- Medically and psychiatrically stable defined as not requiring inpatient treatment.
Who cannot join
- Inability to provide informed consent.
- Need for inpatient treatment
- Need for inpatient detoxification for substance other than alcohol
- Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen.
- Medically or psychiatrically unstable patients, defined as requiring inpatient treatment.
- Pregnancy, nursing or refusal to use a reliable method of birth control in women.
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- Current treatment with other antipsychotic medications, which cannot be switched to Seroquel SR.
- Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR.
- Exclude patients (pts) with unstable diabetes.
- Exclude pts over 65
- Exclude pts with dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Department of Psychiatry
Omaha, Nebraska, 68131
About this study
Official title: 12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3 approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety disorders is unknown. This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures include craving for alcohol, length of sobriety from drinking and level of anxiety with Seroquel SR.
Read the detailed description
STUDY OBJECTIVES:
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety in a prospective double blind placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they can receive group/self help group therapy.
Method:
This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential candidates will be allowed sufficient time to review the consent document and ask questions about the trial prior to signing the consent document. Consenting adults will be randomized to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20 patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All participants will also be referred to usual alcohol treatment, including individual, group and/or self help group therapy (Alcoholics Anonymous).
Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR will occur on the following schedule: At the baseline visit, Seroquel SR will be started at 50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose reductions (because of physical illness or adverse event) are allowed for patients taking at least 200 mg per day.
- Conditions
- Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder, Post-Traumatic Stress Disorder, Panic Disorder, Obsessive-Compulsive Disorder
- Being tested
- Seroquel XR
- Keywords
- Alcoholism, Anxiety, GAD, PTSD, Panic Disorder, OCD
- Medical subject headings
- Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder, Stress Disorders, Post-Traumatic, Panic Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroquel XRDrug
Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Subjects will be randomized to receive either Seroquel SR or placebo Receives: Drug: Seroquel XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety.
Measured: Two Years
Secondary outcomes (2)
Aim 2: To determine whether Seroquel SR decreases craving as measured by the Pennsylvania Craving Scale, in individuals with alcohol dependence and co-morbid anxiety.
Measured: Two Years
Aim 3: To determine whether Seroquel SR reduces anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety (HAM-A), in individuals with alcohol dependence and co-morbid anxiety.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2008
- Study completionNov 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Pirzada Sattar, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352469
- Sponsor's protocol ID
- IRUSQUET408
- Status last verified
- Dec 2008
- First submitted
- 12 Jul 2006
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
- ClinicalTrials.gov ID
- NCT00352469
- Acronym / sponsor ID
- IRUSQUET408
- Conditions
- Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder, Post-Traumatic Stress Disorder, Panic Disorder, Obsessive-Compulsive Disorder
- Keywords
- Alcoholism, Anxiety, GAD, PTSD, Panic Disorder, OCD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Jul 2006 (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.
Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3 approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety disorders is unknown. This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures include craving for alcohol, length of sobriety from drinking and level of anxiety with Seroquel SR.
Detailed description
STUDY OBJECTIVES:
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety in a prospective double blind placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they can receive group/self help group therapy.
Method:
This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential candidates will be allowed sufficient time to review the consent document and ask questions about the trial prior to signing the consent document. Consenting adults will be randomized to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20 patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All participants will also be referred to usual alcohol treatment, including individual, group and/or self help group therapy (Alcoholics Anonymous).
Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR will occur on the following schedule: At the baseline visit, Seroquel SR will be started at 50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose reductions (because of physical illness or adverse event) are allowed for patients taking at least 200 mg per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Seroquel XRSubjects will be randomized to receive either Seroquel SR or placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of alcohol dependence and an anxiety disorder (generalized anxiety disorder, post traumatic disorder, panic disorder, obsessive compulsive disorder, etc.) based on Mini-International Neuropsychiatric Interview (MINI) for DSM IV.
- Subject reports a minimum of 48 standard alcoholic drinks (or an average of 12 drinks/wk) in a consecutive 30-day period (i.e., a minimum of 40% days drinking), and has 2 or more days of heavy drinking (defined as ≥5 drinks/day in males and ≥4 drinks/day in females) in this same period as measured by the Time Line Follow Back.
- Male and female patients between 19-65 years of age.
- Ability to provide informed consent.
- Medically and psychiatrically stable defined as not requiring inpatient treatment.
Key exclusion criteria (11 listed)
- Inability to provide informed consent.
- Need for inpatient treatment
- Need for inpatient detoxification for substance other than alcohol
- Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen.
- Medically or psychiatrically unstable patients, defined as requiring inpatient treatment.
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 |
|---|---|---|
| Seroquel XRDay 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg | Drug | 2 |
Primary outcome
Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety.
Time frame: Two Years
2 secondary outcomes
Aim 2: To determine whether Seroquel SR decreases craving as measured by the Pennsylvania Craving Scale, in individuals with alcohol dependence and co-morbid anxiety.
Time frame: Two Years
Aim 3: To determine whether Seroquel SR reduces anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety (HAM-A), in individuals with alcohol dependence and co-morbid anxiety.
Time frame: Two years
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 8 Dec 2008.
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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.
Pirzada Sattar, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seroquel XR in people with Alcoholism and Anxiety Disorders, run by Creighton University 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 5 inclusion and 11 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 8 Dec 2008. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety. (time frame: Two Years). It is what the study was designed to measure, not a finding.
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 8 Dec 2008.