AlcoholismPhase 3NCT00124059
Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.
A Phase 3 study testing Seroquel in people with Alcoholism, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Seroquel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2005
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female and 18-65 years old.
- Has a DSM-IV diagnosis of current alcohol dependence.
- Has either Type A or Type B alcohol dependence, determined by cut-off scores for drinking amounts per day (TLFB), depression symptoms (Hamilton Depression Rating Scale--HDRS; Hamilton, 1967), and number of childhood antisocial personality symptoms. These three variables were selected based on recently published data on alcohol subtyping by Pettinati et al., 2000b).
- Meets the following drinking criteria, measured by TLFB: a. drink within 30 days of starting pharmacotherapy treatment, b. reports a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting pharmacotherapy (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period. [Note: To be a subject in the study, the patient must have been drinking enough in the 90 days before the trial so that a baseline exists in order to then measure reductions in drinking during the trial.]
- Prior to starting pharmacotherapy, scores below 8 on the Clinical Institutes Withdrawal Assessment for Alcohol (CIWA; Shaw et al, 1981), and has at least 3 consecutive days of abstinence, as determined by subject report, breathalyzer measures, and a collateral report.
- Speaks, understands and prints in English.
- Gives written informed consent.
Who cannot join
- Has evidence of dependence on a substance other than alcohol (except nicotine), test positive on the urine drug screen (with the exception of THC) in the screening week (only one repeat testing permitted), or require inpatient detoxification for any substance.
- Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3).
- Patients with hepatocellular disease as evidenced by AST or ALT levels at least 2 times normal who test positive on a screening test for hepatitis A, B or C.
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
- Has taken any psychotropic medications (or disulfiram) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep);
- Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the S is of child-bearing potential.
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- Has known hypersensitivity to antipsychotics.
- Has participated in any investigational drug trial within 30 days prior to the study.
- History of seizures including alcohol withdrawal seizures.
- History of head trauma.
- Family history of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics.
The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence.
Read the detailed description
The purpose of this study is to obtain preliminary data regarding the safety, efficacy and tolerability of quetiapine [Seroquel (SQL)] in treating Type A vs B alcohol dependent outpatients seeking treatment.
- Conditions
- Alcoholism
- Being tested
- Seroquel, Placebo
- Keywords
- alcohol dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroquelDrug
400mg/day quetiapine
PlaceboDrug
400mg/day placebo
| Study group | Role | What they receive |
|---|---|---|
| Type A SERO | Experimental | Not described Receives: Drug: Seroquel |
| Type B SERO | Experimental | Not described Receives: Drug: Seroquel |
| Type A PLA | Placebo comparator | Not described Receives: Drug: Placebo |
| Type B PLA | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLFB (TimeLine FollowBack) for 1) proportion of days abstinent; 2) proportion of days of heavy drinking; 3) time to the return of heavy drinking (drinking heavily for 2 out of 30 days).
Measured: 13 weeks
Secondary outcomes (1)
1. Patient acceptability of the pharmacotherapy (measured by treatment drop outs and pill noncompliance) 2. Changes in craving for alcohol over the course of treatment 3. Changes in any mood and anxiety symptoms over the course of treatment
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startMar 2003
- Primary completionSep 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen M Pettinati, PhD, Principal investigator, University of Pennsylvania Treatment Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124059
- Sponsor's protocol ID
- 706689
- Status last verified
- Sep 2013
- First submitted
- 22 Jul 2005
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kampman KM, Pettinati HM, Lynch KG, Whittingham T, Macfadden W, Dackis C, Tirado C, Oslin DW, Sparkman T, O'Brien CP. A double-blind, placebo-controlled pilot trial of quetiapine for the treatment of Type A and Type B alcoholism. J Clin Psychopharmacol. 2007 Aug;27(4):344-51. doi: 10.1097/JCP.0b013e3180ca86e5.
PubMed 17632217
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics.
- ClinicalTrials.gov ID
- NCT00124059
- Acronym / sponsor ID
- 706689
- Conditions
- Alcoholism
- Keywords
- alcohol dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 26 Jul 2005 (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.
The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence.
Detailed description
The purpose of this study is to obtain preliminary data regarding the safety, efficacy and tolerability of quetiapine [Seroquel (SQL)] in treating Type A vs B alcohol dependent outpatients seeking treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type A SERO | Experimental | Drug: Seroquel |
| Type B SERO | Experimental | Drug: Seroquel |
| Type A PLA | Placebo comparator | Drug: Placebo |
| Type B PLA | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female and 18-65 years old.
- Has a DSM-IV diagnosis of current alcohol dependence.
- Has either Type A or Type B alcohol dependence, determined by cut-off scores for drinking amounts per day (TLFB), depression symptoms (Hamilton Depression Rating Scale--HDRS; Hamilton, 1967), and number of childhood antisocial personality symptoms. These three variables were selected based on recently published data on alcohol subtyping by Pettinati et al., 2000b).
- Meets the following drinking criteria, measured by TLFB: a. drink within 30 days of starting pharmacotherapy treatment, b. reports a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting pharmacotherapy (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period. [Note: To be a subject in the study, the patient must have been drinking enough in the 90 days before the trial so that a baseline exists in order to then measure reductions in drinking during the trial.]
- Prior to starting pharmacotherapy, scores below 8 on the Clinical Institutes Withdrawal Assessment for Alcohol (CIWA; Shaw et al, 1981), and has at least 3 consecutive days of abstinence, as determined by subject report, breathalyzer measures, and a collateral report.
Key exclusion criteria (11 listed)
- Has evidence of dependence on a substance other than alcohol (except nicotine), test positive on the urine drug screen (with the exception of THC) in the screening week (only one repeat testing permitted), or require inpatient detoxification for any substance.
- Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3).
- Patients with hepatocellular disease as evidenced by AST or ALT levels at least 2 times normal who test positive on a screening test for hepatitis A, B or C.
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
- Has taken any psychotropic medications (or disulfiram) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep);
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 |
|---|---|---|
| Seroquel400mg/day quetiapine | Drug | Type A SERO, Type B SERO |
| Placebo400mg/day placebo | Drug | Type A PLA, Type B PLA |
Primary outcome
TLFB (TimeLine FollowBack) for 1) proportion of days abstinent; 2) proportion of days of heavy drinking; 3) time to the return of heavy drinking (drinking heavily for 2 out of 30 days).
Time frame: 13 weeks
1 secondary outcome
1. Patient acceptability of the pharmacotherapy (measured by treatment drop outs and pill noncompliance) 2. Changes in craving for alcohol over the course of treatment 3. Changes in any mood and anxiety symptoms over the course of treatment
Time frame: 13 weeks
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 6 Oct 2015.
- Results publication: PubMed 17632217Kampman KM, Pettinati HM, Lynch KG, Whittingham T, Macfadden W, Dackis C, Tirado C, Oslin DW, Sparkman T, O'Brien CP. A double-blind, placebo-controlled pilot trial of quetiapine for the treatment of Type A and Type B alcoholism. J Clin Psychopharmacol. 2007 Aug;27(4):344-51. doi: 10.1097/JCP.0b013e3180ca86e5.
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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.
Helen M Pettinati, PhD principal investigator
University of Pennsylvania Treatment Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seroquel in people with Alcoholism, run by University of Pennsylvania 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 7 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 6 Oct 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
TLFB (TimeLine FollowBack) for 1) proportion of days abstinent; 2) proportion of days of heavy drinking; 3) time to the return of heavy drinking (drinking heavily for 2 out of 30 days). (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124059, which also lists 1 linked publication.
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 6 Oct 2015.