Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
2 other identifiers
interventional
56
1 country
1
Brief Summary
The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 19, 2016
CompletedJune 24, 2016
May 1, 2016
3.3 years
March 5, 2012
February 2, 2016
May 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Craving to Drink
Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
1 week
Secondary Outcomes (1)
Drinking
2 weeks
Study Arms (2)
Korlym (mifepristone)
ACTIVE COMPARATOR600 mg daily taken orally for one week
Sugar Pill
PLACEBO COMPARATORplacebo pill daily taken orally for one week
Interventions
600 mg/day, oral pill, 7 days
Eligibility Criteria
You may qualify if:
- Male or female volunteers, 18-65 years of age
- Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV) criteria for current alcohol dependence
- Subjects will not be seeking treatment because the medication studies are not treatment trials
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
- Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) score of \< 8 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
- Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
You may not qualify if:
- Significant medical disorders that will increase potential risk or interfere with study participation as determined by the Study Physician
- Female subjects with childbearing potential who are pregnant, nursing, or refuse to use double barrier (non-hormonal) methods of birth control for the duration of the study and one month thereafter
- Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders or substance dependence disorders other than alcohol or nicotine dependence
- History of allergy or hypersensitivity to the study drugs or the ingredients
- Treatment within the month prior to screening with 1.) an investigational drug or vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.
- In need of or currently taking any psychoactive medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Scripps Research Institute
La Jolla, California, 92037, United States
Related Publications (1)
Vendruscolo LF, Estey D, Goodell V, Macshane LG, Logrip ML, Schlosburg JE, McGinn MA, Zamora-Martinez ER, Belanoff JK, Hunt HJ, Sanna PP, George O, Koob GF, Edwards S, Mason BJ. Glucocorticoid receptor antagonism decreases alcohol seeking in alcohol-dependent individuals. J Clin Invest. 2015 Aug 3;125(8):3193-7. doi: 10.1172/JCI79828. Epub 2015 Jun 29.
PMID: 26121746DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara J. Mason, Ph.D.
- Organization
- The Scripps Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara J Mason, PhD
The Scripps Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 8, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
June 24, 2016
Results First Posted
May 19, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share