Clinical trial NCT02179749: Mifepristone Treatment of Alcohol Use Disorder
Official title: Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Alcohol Use Disorders
Alcohol Abuse
Alcoholism
Keywords: Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Mifepristone
Glucocorticoid Antagonists
Alcohol Treatment
Alcohol
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-07-02
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Drinking Quantity Per Day
timeFrame: Participants will be followed for up to 12 weeks post-assignment
Secondary outcomes:
measure: Craving
timeFrame: Participants will be followed for up to 12 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: