Alcohol DependencePhase 2NCT02179749
Mifepristone Treatment of Alcohol Use Disorder
A Phase 2 study testing Mifepristone 1200 mg daily and Standardized behavioral therapy in people with Alcohol Dependence and Alcohol Use Disorders, run by The Scripps Research Institute at 1 site in United States.
Trial summary
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Alcohol Use Disorders, Alcohol Abuse
- What is being tested?
- Mifepristone 1200 mg daily and Standardized behavioral therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 6 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers, 18-65 years of age
- Meets Diagnostic and Statistical Manual (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
- Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
- In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
- Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter
Who cannot join
- A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
- Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
- Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
- Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute
La Jolla, California, 92037
About this study
Official title: Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.
- Conditions
- Alcohol Dependence, Alcohol Use Disorders, Alcohol Abuse, Alcoholism
- Being tested
- Mifepristone 1200 mg daily, Standardized behavioral therapy, Placebo
- Keywords
- Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mifepristone, Glucocorticoid Antagonists, Alcohol Treatment, Alcohol
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 1200 mg dailyDrug
Also called Korlym
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Standardized behavioral therapyBehavioural
Also called Manually-guided therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
PlaceboDrug
Also called Placebo Comparator
Placebo tablets, Four tablets daily/am for 1-week duration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: mifepristone 1200 mg daily | Active comparator | 1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Receives: Drug: Mifepristone 1200 mg daily; Behavioral: Standardized behavioral therapy |
| Placebo daily, 1-week | Placebo comparator | Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy Receives: Behavioral: Standardized behavioral therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking Quantity Per Day
Drinking quantity in standard drinks per day is measured by the Timeline Followback interview.
A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
Measured: Participants will be followed for up to 12 weeks post-assignment
Secondary outcomes (1)
Craving
Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
Measured: Participants will be followed for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Barbara J. Mason, Ph.D, Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179749
- Sponsor's protocol ID
- 1R01AA023152
- Status last verified
- Sep 2022
- First submitted
- 26 Jun 2014
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT02179749
- Acronym / sponsor ID
- 1R01AA023152
- Conditions
- Alcohol Dependence, Alcohol Use Disorders, Alcohol Abuse, Alcoholism
- Keywords
- Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mifepristone, Glucocorticoid Antagonists, Alcohol Treatment, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2014
- Primary completion
- Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: mifepristone 1200 mg daily | Active comparator | Drug: Mifepristone 1200 mg daily, Behavioral: Standardized behavioral therapy1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy |
| Placebo daily, 1-week | Placebo comparator | Behavioral: Standardized behavioral therapy, Drug: PlaceboPlacebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female volunteers, 18-65 years of age
- Meets Diagnostic and Statistical Manual (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
- Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
- In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
- Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter
Key exclusion criteria (5 listed)
- A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
- Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
- Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
- Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone 1200 mg dailyAlso: KorlymMifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration. | Drug | Experimental: mifepristone 1200 mg daily |
| Standardized behavioral therapyAlso: Manually-guided therapyStandardized behavioral therapy 1 time per week for 8 week duration. | Behavioural | Experimental: mifepristone 1200 mg daily, Placebo daily, 1-week |
| PlaceboAlso: Placebo ComparatorPlacebo tablets, Four tablets daily/am for 1-week duration. | Drug | Placebo daily, 1-week |
Primary outcome
Drinking Quantity Per Day
Time frame: Participants will be followed for up to 12 weeks post-assignment
Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
1 secondary outcome
Craving
Time frame: Participants will be followed for up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J. Mason, Ph.D principal investigator
The Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone 1200 mg daily and Standardized behavioral therapy in people with Alcohol Dependence and Alcohol Use Disorders, run by The Scripps Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking Quantity Per Day (time frame: Participants will be followed for up to 12 weeks post-assignment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.