Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Alcoholism Clinical Trial

Official title:

Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548417
• Other study ID #: AA012602-11A1
• Secondary ID: 2R01AA012602-11A
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: October 29, 2015
• Start date: March 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following cue- and stress induced exposure in the laboratory and report fewer symptoms of protracted abstinence (e.g., craving, anxiety, mood and sleep disturbances) under naturalistic conditions, significantly more than those treated with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female volunteers, 18-65 years of age

• Meets 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 BAC and a CIWA 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Korlym (mifepristone)
600 mg/day, oral pill, 7 days
• Sugar Pill
600 mg/day, oral pill, 7 days

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	Craving to Drink	Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues.	1 week	No
Secondary	Drinking	Number of standard drinks per week using the Timeline Followback Interview	2 weeks	No

External Links

•   Laboratory Website
•   Laboratory Website Contact Form