Phase 2
N=218
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Alcoholism · Alcohol Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00498628 ↗Enrolled (actual)
218
Serious AEs
5.1%
Results posted
May 2012
Primary outcome: Primary: Percent Heavy Drinking Days — 37.1; 37.9 percentage of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quetiapine fumarate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Primary completion
- Aug 2009
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 | — |
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.
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.