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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02179749
Other study ID # 1R01AA023152
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2014
Est. completion date November 6, 2019

Study information

Verified date September 2022
Source The Scripps Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date November 6, 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female volunteers, 18-65 years of age - Meets Diagnostic and Statistical Manual (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as = 4 symptoms - Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization - In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests - Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter Exclusion Criteria: - A medical condition or chronic use of a medication that contraindicates the administration of mifepristone - Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized - Liver function tests more than 3 times the upper limit of normal or elevated bilirubin - Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter - Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders

Study Design


Intervention

Drug:
Mifepristone 1200 mg daily
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Behavioral:
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Drug:
Placebo
Placebo tablets, Four tablets daily/am for 1-week duration.

Locations

Country Name City State
United States The Scripps Research Institute La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
The Scripps Research Institute National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drinking Quantity Per Day Drinking quantity in standard drinks per day is measured by the Timeline Followback interview.
A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
Participants will be followed for up to 12 weeks post-assignment
Secondary Craving Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol. Participants will be followed for up to 12 weeks
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