Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
This study is currently recruiting participants.
Verified July 2012 by The Scripps Research Institute
Sponsor:
The Scripps Research Institute
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT01548417
First received: March 5, 2012
Last updated: July 25, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: Korlym (mifepristone) Drug: Sugar Pill |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists |
Resource links provided by NLM:
Further study details as provided by The Scripps Research Institute:
Primary Outcome Measures:
- Craving to Drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cognitive Functioning [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Korlym (mifepristone) |
Drug: Korlym (mifepristone)
600 mg/day, oral pill, 7 days
Other Names:
|
| Placebo Comparator: Sugar Pill |
Drug: Sugar Pill
600 mg/day, oral pill, 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548417
Contacts
| Contact: Amanda E Higley, PhD | 858-784-7331 | ahigley@scripps.edu |
| Contact: Susan Quello, B.S. | 858-784-7327 | squello@scripps.edu |
Locations
| United States, California | |
| The Scripps Research Institute | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Amanda E Higley, Ph.D. 858-784-7331 ahigley@scripps.edu | |
| Principal Investigator: Barbara J Mason, Ph.D. | |
Sponsors and Collaborators
The Scripps Research Institute
Investigators
| Principal Investigator: | Barbara J Mason, PhD | The Scripps Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara J. Mason, PI, The Scripps Research Institute |
| ClinicalTrials.gov Identifier: | NCT01548417 History of Changes |
| Other Study ID Numbers: | AA012602-11A1, 2R01AA012602-11A1 |
| Study First Received: | March 5, 2012 |
| Last Updated: | July 25, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by The Scripps Research Institute:
|
Alcohol Relapse |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Glucocorticoids Mifepristone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 22, 2013