Clinical trial NCT01548417: Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
Official title: Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: Alcohol
Relapse
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-03-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Craving to Drink
timeFrame: 1 week
Secondary outcomes:
measure: Drinking
timeFrame: 2 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, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.