INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02989662|
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Mifepristone Drug: Placebo - Cap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Glucocorticoid Antagonists in Heavy Drinkers: Effects on fMRI Connectivity, Withdrawal and Drinking|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: Mifepristone
Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
Participants receive 6 doses.
Other Name: Korlym
Placebo Comparator: Placebo - Cap
This is an inactive compound which appears physically identical to active medication.
Drug: Placebo - Cap
Participants receive 6 doses
- fMRI function connectivity [ Time Frame: Change from baseline to day 4 of MIFE dosing ]fMRI data including resting state and alcohol cue induced measures
- Alcohol motivated responding [ Time Frame: single session on study day 5 ]Participants can earn up to 5 standard drinks during a 1-hr session.
- Alcohol sensitivity [ Time Frame: single session on study day 6 ]Subjective and physiological effects of alcohol are measured repeatedly during a 4-hr session
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989662
|Contact: Gary Wand, MDfirstname.lastname@example.org|
|Contact: Mary E McCaul, PhDemail@example.com|
|Principal Investigator:||Gary Wand, MD||Johns Hopkins University|