Phase 2
Completed N=218
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Alcoholism · Alcohol Abuse
Source: ClinicalTrials.gov NCT00498628 ↗
Enrolled (actual)
218
Serious AEs
5.1%
Results posted
May 2012
Primary outcomePrimary: Percent Heavy Drinking Days — 37.1; 37.9 percentage of heavy drinking days
Summary
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Heavy Drinking Days |
37.1; 37.9 | — |
| SECONDARY Percent Days Abstinent |
49.5; 47.1 | — |
| SECONDARY Drinks Per Drinking Day |
6.2; 6.3 | — |
| SECONDARY Drinks Per Day |
4.3; 4.4 | — |
| SECONDARY Percent Very Heavy Drinking Day |
16.5; 18.8 | — |
| SECONDARY Percent Subjects Abstinent |
12; 12 | — |
| SECONDARY Percent Subjects With no Heavy Drinking Day |
17; 24 | — |
| SECONDARY Drinking Consequences Score |
18.5; 22.5 | — |
| SECONDARY Penn Alcohol Craving Score (PACS_ |
12.1; 12.8 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
2.8; 4.1 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) |
2.4; 3.0 | — |
| SECONDARY Pittsburgh Sleep Quality Score |
4.1; 5.1 | — |
| SECONDARY Quality of Life SF - 12 - Mental Aggregate Score |
51.5; 50.7 | — |
| SECONDARY Quality of Life SF-12 - Physical Aggregate Score |
51.0; 50.6 | — |
Eligibility Criteria
Inclusion Criteria
- Between the ages of 18 and 65 years old
- DSM-IV diagnosis of current alcohol dependence as supported by SCID Module E
- Report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more drinks per drinking day for women) at least 40% of the days during the interval from day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this 60-day period), with at least one day of "very heavy" drinking occurring within the last 2 weeks before screening
- Seeking treatment for alcohol dependence and desire reduction or cessation of drinking
- Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Females of child bearing potential must agree to use of at least one approved method of birth control, or must be surgically sterile or postmenopausal
- Able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits
- Able to understand written and oral instructions in English and to complete the questionnaires required by the protocol
- Can complete all psychological assessments required at screening and baseline
- Able to provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to study site, and have no plans to move within the next 3 months or unresolved legal problems; must provide contact information of family member, spouse, or significant other who can contact subject in case of missed appointment
- Breath alcohol concentration (BAC) equal to 0.00 when s/he signed the informed consent document
- Must have an absolute neutrophil count of 1.5 x 109/L or greater.
Exclusion Criteria
Please contact site for additional information.
Data sourced from ClinicalTrials.gov (NCT00498628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.