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CompletedNCT00124059Updated Oct 6, 2015

Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.

A Phase 3 interventional study of Seroquel and Placebo in Alcoholism, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-06.

Sponsored by University of Pennsylvania · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Alcoholism

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Keywords

  • alcohol dependence
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 61 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female and 18-65 years old.
  2. Has a DSM-IV diagnosis of current alcohol dependence.
  3. 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).
  4. 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.]
  5. 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.
  6. Speaks, understands and prints in English.
  7. Gives written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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).
  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.
  4. 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.
  5. 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);
  6. 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.
  7. Has known hypersensitivity to antipsychotics.
  8. Has participated in any investigational drug trial within 30 days prior to the study.
  9. History of seizures including alcohol withdrawal seizures.
  10. History of head trauma.
  11. Family history of seizures.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Type A SERO

    Drug: Seroquel

  • Experimental
    Type B SERO

    Drug: Seroquel

  • Placebo comparator
    Type A PLA

    Drug: Placebo

  • Placebo comparator
    Type B PLA

    Drug: Placebo

Interventions

  • DrugSeroquel

    400mg/day quetiapine

  • DrugPlacebo

    400mg/day placebo

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What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 13 weeks

07

Study locations

1 site
  • University of Pennsylvania Treatment Research Center
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00124059
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jul 26, 2005
Start date
Mar 2003
Primary completion
Sep 2005
Completion
Oct 2005
Last update
Oct 6, 2015

Study contacts

Helen M Pettinati, PhD
principal investigator · University of Pennsylvania Treatment Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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